Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-01 @ 12:27 PM
Study NCT ID:
NCT01549535
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyp Detection With The Peerscope System™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}, {'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-03-08', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'polyp detection rate', 'timeFrame': '1 year', 'description': 'Sample size calculation is based on detecting a difference in the adenoma overall detection rate and the overall polyp detection rate using the PeerScope System™ extended view as compared to Standard view colonoscopy.\n\nTotal sample size will be 196 patients. Each patient will undergo the procedure by the two devices: PeerScope System™ extended view and Standard view colonoscopy. The rational for this sample size is based on detecting a rate difference of 20% between the study devices.'}]}, 'conditionsModule': {'conditions': ['Colon Polyps and Adenomas', 'Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '24560453', 'type': 'DERIVED', 'citation': "Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20."}]}, 'descriptionModule': {'briefSummary': 'The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.\n\nObjective:To compare the additional diagnostic yield obtained by using the PeerScope System™ extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.\n\nIn addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.', 'detailedDescription': 'Design:\n\nPatients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.\n\nSubjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy. Subjects in Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.\n\nResults from the two groups will be analyzed and compared, with primary outcome measures being detection rates for total polyps and detection rates for adenomas. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.\n\nSubjects will be followed through a 24 hour and a 7 days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.\n\nStudy Design:\n\nMulti-center study with up to 196 patients. No. of Patients:\n\nUp to 196 treated patients will be enrolled into the study. Primary Performance Endpoint:\n\n* Standard view colonoscopy adenoma overall detection rate compared to the extended view overall adenoma detection rate using the PeerScope System™\n* Standard view colonoscopy overall polyp detection rate compared to the extended view overall polyp detection rate using the PeerScope System™.\n\nSafety Analysis:\n\nIncidence of device-related and procedure-related serious adverse events. Incidence of complications using PeerScope System™\n\nKnown complications include:\n\n* Perforation;\n* Severe abdominal pain;\n* Infection;\n* Bleeding (other than expected minor bleeding due to therapeutic procedures e.g. polypectomy);\n* Inducing inflammation of diverticulum\n* Arrhythmia, bradycardia, hypotension, hypoxia\n* Death\n\nSecondary Endpoints / Other Outcomes:\n\n1. Performance of therapeutic interventions, such as biopsies, polypectomies, APC etc.\n2. Procedure time. The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured\n3. Sedation dosage\n4. Patient satisfaction. Patient\'s pain at the end of the procedure will be recorded using VAS scale. Results of 24 hour telephone follow-up to assess for post-procedural patient satisfactory will be recorded on the CRF.\n\nInclusion criteria:\n\n* Subject between the ages of 18 and 70\n* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;\n* Written informed consent must be available before enrollment in the trial\n* For women with childbearing potential, adequate contraception\n\nExclusion criteria:\n\n* Patients with a history of colonic resection;\n* Patients with known (or newly diagnosed) inflammatory bowel disease;\n* Patients with a personal history of polyposis syndrome;\n* Patients with suspected chronic stricture potentially precluding complete colonoscopy;\n* Patients with diverticulitis or toxic megacolon;\n* Patients with a history of radiation therapy to abdomen or pelvis;\n* Patients with acute lower GI bleeding\n* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient\'s participation in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject between the ages of 18 and 70\n* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;\n* Written informed consent must be available before enrollment in the trial\n* For women with childbearing potential, adequate contraception\n\nExclusion Criteria:\n\n* Patients with a history of colonic resection;\n* Patients with known (or newly diagnosed) inflammatory bowel disease;\n* Patients with a personal history of polyposis syndrome;\n* Patients with suspected chronic stricture potentially precluding complete colonoscopy;\n* Patients with diverticulitis or toxic megacolon;\n* Patients with a history of radiation therapy to abdomen or pelvis;\n* Patients with acute lower GI bleeding\n* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study."}, 'identificationModule': {'nctId': 'NCT01549535', 'briefTitle': 'Polyp Detection With The Peerscope System™', 'organization': {'class': 'INDUSTRY', 'fullName': 'PeerMedical Ltd.'}, 'officialTitle': 'Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study', 'orgStudyIdInfo': {'id': 'CD-1158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (study group)', 'description': 'Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy.', 'interventionNames': ['Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (control group)', 'description': 'Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.', 'interventionNames': ['Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system']}], 'interventions': [{'name': 'Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system', 'type': 'DEVICE', 'otherNames': ['Colonoscopy', 'Polyp detection', 'Screening'], 'description': 'endoscopic diagnosis, treatment and video observation of the digestive tract, endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients', 'armGroupLabels': ['Group A (study group)', 'Group B (control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Gasstroenterology Assoiates, P.C.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Southshore Gasstroenterology, P.C', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Elisha Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Ian Gralnek, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Peter Siersema, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}, {'name': 'Erwin Santo, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Tel Aviv Sourasky Medical Center'}, {'name': 'Ori Segol, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}, {'name': 'Alan Sloyer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore Gastroenterology Associates, P.C.'}, {'name': 'Jay S. Fenster, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southshore Gasstroenterology, P.C'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PeerMedical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}