Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-01 @ 4:07 PM
Study NCT ID:
NCT05725967
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-02
First Post:
2022-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Metabolic and Bariatric Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D005747', 'term': 'Gastric Fistula'}, {'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C038767', 'term': 'immunoglobulin B'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D057908', 'term': 'Argon Plasma Coagulation'}, {'id': 'D015391', 'term': 'Gastroplasty'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D006488', 'term': 'Hemostasis, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2022-12-29', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': '%TBWL'}, {'measure': 'Change in hypertension from pre-procedure to 10 years using blood pressure measurements', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.'}, {'measure': 'Change in hypertension from pre-procedure to 10 years using medication dosages', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.'}, {'measure': 'Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.'}, {'measure': 'Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change of HgA1c (%) by comparing lab values from baseline through 10 years.'}, {'measure': 'Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.'}, {'measure': 'Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.'}, {'measure': 'Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.'}, {'measure': 'Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.'}, {'measure': 'Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.'}, {'measure': 'Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.'}, {'measure': 'Change in rate of adverse events from procedure to 10 years', 'timeFrame': 'Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change in rate of adverse events post-procedure through 10 years'}, {'measure': 'Change in comorbidity medication dosages from baseline to 10 years', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Change of dosage of comorbidity medications compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Change in gastric motility from baseline to 10 years', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Gastric emptying breath test'}, {'measure': 'Change in PYY gut hormones from baseline to 10 years', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'PYY lab values will be compared to baseline'}, {'measure': 'Change in GLP1 gut hormones from baseline to 10 years', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'GLP1 lab values will be compared to baseline'}, {'measure': 'Change in ghrelin hormones from baseline to 10 years', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.', 'description': 'Ghrelin lab values will be compared to baseline'}, {'measure': 'Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years', 'timeFrame': 'Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery', 'description': 'Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Roux-en-Y Gastric Bypass', 'Sleeve Gastrectomy', 'laparoscopic adjustable gastric banding', 'gastroplasty with endoscopic myotomy (GEM)', 'endoscopic sleeve gastroplasty (ESG)', 'transoral outlet reduction (TORe)', 'primary obesity surgery endoluminal (POSE)', 'restorative obesity surgery endoluminal (ROSE)', 'intragastric balloons (IGB)', 'aspiration therapy', 'pylorus sparing antral myotomy (PSAM)', 'gastric emptying breath test (GEBT)'], 'conditions': ['Obesity', 'Obesity, Morbid', 'Obesity Associated Disorder', 'Bariatric Surgery Candidate', 'Fistula, Gastric', 'Roux-en-y Anastomosis Site', 'Ulcer, Gastric', 'Abdominal Pain', 'Abdominal Obesity', 'Complication of Surgical Procedure', 'Complication of Treatment', 'Complication,Postoperative', 'Weight Gain', 'Weight Loss', 'Leak, Anastomotic', 'Delayed Gastric Emptying Following Procedure']}, 'referencesModule': {'references': [{'pmid': '35908555', 'type': 'BACKGROUND', 'citation': 'Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.'}, {'pmid': '35259393', 'type': 'BACKGROUND', 'citation': 'Jirapinyo P, Thompson CC. Endoscopic gastric plication for the treatment of weight regain after Roux-en-Y gastric bypass (with video). Gastrointest Endosc. 2022 Jul;96(1):51-56. doi: 10.1016/j.gie.2022.02.051. Epub 2022 Mar 5.'}, {'pmid': '34374043', 'type': 'BACKGROUND', 'citation': 'de Moura DTH, Hirsch BS, Boghossian MB, de Medeiros FS, McCarty TR, Thompson CC, de Moura EGH. Low-cost modified endoscopic vacuum therapy using a triple-lumen tube allows nutrition and drainage for treatment of an early post-bariatric surgery leak. Endoscopy. 2022 Jul;54(7):E376-E377. doi: 10.1055/a-1540-5870. Epub 2021 Aug 9. No abstract available.'}, {'pmid': '34243196', 'type': 'BACKGROUND', 'citation': 'de Moura DTH, de Freitas Junior JR, de Souza GMV, de Oliveira GHP, McCarty TR, Thompson CC, de Moura EGH. Endoscopic management of acute leak after sleeve gastrectomy: principles and techniques. Endoscopy. 2022 Jul;54(7):E327-E328. doi: 10.1055/a-1525-1661. Epub 2021 Jul 9. No abstract available.'}, {'pmid': '35589208', 'type': 'BACKGROUND', 'citation': 'Sanchez-Luna SA, Thompson CC, De Moura EGH, de Medeiros FS, De Moura DTH. Modified endoscopic vacuum therapy: Are we ready for prime time? Gastrointest Endosc. 2022 Jun;95(6):1281-1282. doi: 10.1016/j.gie.2021.12.049. No abstract available.'}, {'pmid': '34669046', 'type': 'BACKGROUND', 'citation': 'Bazarbashi AN, Dolan RD, McCarty TR, Jirapinyo P, Thompson CC. Endoscopic revision of gastrojejunal anastomosis for the treatment of dumping syndrome in patients with Roux-en-Y gastric bypass: a systematic review and meta-analysis. Surg Endosc. 2022 Jun;36(6):4099-4107. doi: 10.1007/s00464-021-08731-4. Epub 2021 Oct 20.'}, {'pmid': '35348970', 'type': 'BACKGROUND', 'citation': 'Jirapinyo P, Thompson CC. Primary Bariatric Procedures. Dig Dis Sci. 2022 May;67(5):1674-1687. doi: 10.1007/s10620-022-07393-z. Epub 2022 Mar 29.'}, {'pmid': '34169433', 'type': 'BACKGROUND', 'citation': 'Argueta PP, Salazar M, Vargo JJ, Chahal P, Rodriguez JJ, Simons-Linares CR, Thompson CC. Thirty-Day Readmission After Bariatric Surgery: Causes, Effects on Outcomes, and Predictors. Dig Dis Sci. 2022 Mar;67(3):834-843. doi: 10.1007/s10620-021-06934-2. Epub 2021 Jun 24.'}, {'pmid': '33727164', 'type': 'BACKGROUND', 'citation': 'Jirapinyo P, McCarty TR, Dolan RD, Shah R, Thompson CC. Effect of Endoscopic Bariatric and Metabolic Therapies on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2022 Mar;20(3):511-524.e1. doi: 10.1016/j.cgh.2021.03.017. Epub 2021 Mar 13.'}, {'pmid': '33523277', 'type': 'BACKGROUND', 'citation': 'Singh S, Bazarbashi AN, Khan A, Chowdhry M, Bilal M, de Moura DTH, Jirapinyo P, Thakkar S, Thompson CC. Primary obesity surgery endoluminal (POSE) for the treatment of obesity: a systematic review and meta-analysis. Surg Endosc. 2022 Jan;36(1):252-266. doi: 10.1007/s00464-020-08267-z. Epub 2021 Feb 1.'}, {'pmid': '35961376', 'type': 'RESULT', 'citation': 'Thompson CC, Jirapinyo P, Shah R, Simsek C. Gastroplasty With Endoscopic Myotomy (GEM) for the Treatment of Obesity: Preliminary Efficacy and Physiologic Results. Gastroenterology. 2022 Nov;163(5):1173-1175. doi: 10.1053/j.gastro.2022.07.077. Epub 2022 Aug 10. No abstract available.'}, {'pmid': '35568242', 'type': 'RESULT', 'citation': 'Jirapinyo P, Thompson CC. Comparison of distal primary obesity surgery endolumenal techniques for the treatment of obesity (with videos). Gastrointest Endosc. 2022 Sep;96(3):479-486. doi: 10.1016/j.gie.2022.04.1346. Epub 2022 May 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.', 'detailedDescription': 'The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients registered with Mass General Brigham affiliate facilities who have undergone an endoscopic primary obesity procedure, an endoscopic bariatric revision procedure, or a bariatric surgical procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients from Mass General Brigham\n* any patient having an endoscopic primary obesity procedure\n* any patient having an endoscopic post-bariatric surgical revision procedure\n* any patient having a bariatric surgical procedure\n\nExclusion Criteria:\n\n* patients without past surgical and medical history medical records in the Mass General Brigham system\n* patients unwilling to allow for medical record review at Mass General Brigham'}, 'identificationModule': {'nctId': 'NCT05725967', 'acronym': 'EMBTs', 'briefTitle': 'Endoscopic Metabolic and Bariatric Therapies', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Endoscopic Metabolic and Bariatric Therapies', 'orgStudyIdInfo': {'id': '2022P001757'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Obesity Endoscopic Procedures', 'description': 'Primary endoscopic procedures for treatment of obesity.', 'interventionNames': ['Procedure: Primary Obesity Endoscopic Procedures', 'Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction', 'Device: Intragastric Balloon', 'Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal', 'Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy', 'Device: Aspiration Therapy']}, {'label': 'Endoscopic Revision of Bariatric Surgical Procedures', 'description': 'Endoscopic revision of post-bariatric surgical complications.', 'interventionNames': ['Procedure: Endoscopic Revision of Bariatric Surgical Procedures', 'Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction', 'Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal', 'Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy']}, {'label': 'Bariatric Surgery Procedures', 'description': 'Bariatric surgical procedures.', 'interventionNames': ['Procedure: Bariatric Surgery Procedures']}], 'interventions': [{'name': 'Primary Obesity Endoscopic Procedures', 'type': 'PROCEDURE', 'otherNames': ['ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs'], 'description': 'Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).', 'armGroupLabels': ['Primary Obesity Endoscopic Procedures']}, {'name': 'Endoscopic Revision of Bariatric Surgical Procedures', 'type': 'PROCEDURE', 'otherNames': ['TORe, ROSE, APC'], 'description': 'Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.', 'armGroupLabels': ['Endoscopic Revision of Bariatric Surgical Procedures']}, {'name': 'Bariatric Surgery Procedures', 'type': 'PROCEDURE', 'otherNames': ['RYGB, LSG, LAGB'], 'description': 'Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)', 'armGroupLabels': ['Bariatric Surgery Procedures']}, {'name': 'Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction', 'type': 'DEVICE', 'otherNames': ['ESG, TORe'], 'description': 'Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.', 'armGroupLabels': ['Endoscopic Revision of Bariatric Surgical Procedures', 'Primary Obesity Endoscopic Procedures']}, {'name': 'Intragastric Balloon', 'type': 'DEVICE', 'otherNames': ['IGB'], 'description': 'An endoscopic bariatric procedure involving the placement of an intragastric balloon.', 'armGroupLabels': ['Primary Obesity Endoscopic Procedures']}, {'name': 'Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal', 'type': 'DEVICE', 'otherNames': ['POSE, ROSE'], 'description': 'Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.', 'armGroupLabels': ['Endoscopic Revision of Bariatric Surgical Procedures', 'Primary Obesity Endoscopic Procedures']}, {'name': 'Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy', 'type': 'DEVICE', 'otherNames': ['APC, GEM, BEAM, PSAM'], 'description': 'Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.', 'armGroupLabels': ['Endoscopic Revision of Bariatric Surgical Procedures', 'Primary Obesity Endoscopic Procedures']}, {'name': 'Aspiration Therapy', 'type': 'DEVICE', 'otherNames': ['Aspire'], 'description': 'Placement of an aspiration therapy device for the treatment of obesity.', 'armGroupLabels': ['Primary Obesity Endoscopic Procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Christopher C. Thompson, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Depending on the range of data and publication status, the PI will consider de-identified data sharing with a data transfer agreement in place after discussion of parameters and study design.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher C. Thompson, MD, MSc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Endoscopy', 'investigatorFullName': 'Christopher C. Thompson, MD, MSc', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}