Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-12 @ 3:32 AM
Study NCT ID:
NCT01799967
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2013-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Surgery of the Gastro-esophageal Junction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}, {'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D016672', 'term': 'Zenker Diverticulum'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004936', 'term': 'Diverticulum, Esophageal'}, {'id': 'D004240', 'term': 'Diverticulum'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-02-26', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MISGEJ symptoms (subjective)', 'timeFrame': '8 years', 'description': 'MISGEJ symptom questionnaire evaluated on an annual basis'}, {'measure': 'Achalasia Disease Severity (subjective)', 'timeFrame': '8 years', 'description': 'Achalasia Disease Severity questionnaire evaluated on an annual basis.'}, {'measure': 'Diagnostic imaging', 'timeFrame': '8 years', 'description': 'Patient x-rays, upper GI tests, Endoscopy, and/or CT scans will be assessed on an annual basis to objectively measure functionality and health status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastro-esophageal junction', 'minimally invasive', 'Achalasia', 'Paraesophageal hernia', 'GERD', 'Epiphrenic diverticula', "Zenker's diverticulum", 'All minimally invasive surgeries of the gastro-esophageal junction'], 'conditions': ['Achalasia', 'Paraesophageal Hernia', 'GERD', 'Epiphrenic Diverticula', "Zenker's Diverticulum"]}, 'descriptionModule': {'briefSummary': 'This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ\n\nExclusion Criteria:\n\n* Less than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT01799967', 'acronym': 'MISGEJ', 'briefTitle': 'Minimally Invasive Surgery of the Gastro-esophageal Junction', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Functional Assessment Following Minimally Invasive Surgery of the Gastro-Esophageal Junction', 'orgStudyIdInfo': {'id': '2007173-01H'}}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Donna E Maziak, MD, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sebastien Gilbert, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sudhir Sundaresan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shamji Farid, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patrick James Villeneuve, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrew JE Seely, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Andrew JE Seely, MD, PhD', 'role': 'CONTACT', 'email': 'aseely@ohri.ca', 'phone': '613-737-8899', 'phoneExt': '74892'}], 'overallOfficials': [{'name': 'Andrew JE Seely, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}