Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT02353533
Status:
UNKNOWN
Last Update Posted:
2016-11-21
First Post:
2015-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2015-01-23', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of resection', 'timeFrame': '3 month', 'description': 'Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment'}], 'secondaryOutcomes': [{'measure': 'Duration of procedure', 'timeFrame': 'up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenoma', 'EMR', 'FTRD', 'non- lifting', 'colon'], 'conditions': ['Adenoma']}, 'descriptionModule': {'briefSummary': 'Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique.\n\nAlternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas.\n\nIn this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients ≥ 18 years\n* adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")\n\nExclusion Criteria:\n\n* patients \\< 18 years\n* lesions \\> 20 mm in size\n* high risk carcinomas ("deep submucosal carcinoma")\n* American Society of Anesthesiologists (ASA) class IV and higher'}, 'identificationModule': {'nctId': 'NCT02353533', 'acronym': 'FiRE', 'briefTitle': 'Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'orgStudyIdInfo': {'id': 'FiRE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EMR', 'description': 'Standard EMR technique', 'interventionNames': ['Device: EMR']}, {'type': 'EXPERIMENTAL', 'label': 'FTRD', 'interventionNames': ['Device: over- the- scope full- thickness resection device (FTRD)']}], 'interventions': [{'name': 'over- the- scope full- thickness resection device (FTRD)', 'type': 'DEVICE', 'description': 'Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device', 'armGroupLabels': ['FTRD']}, {'name': 'EMR', 'type': 'DEVICE', 'description': 'Standard endoscopic mucosal resection using a resection snare', 'armGroupLabels': ['EMR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Klare, MD', 'role': 'CONTACT', 'email': 'peter.klare@lrz.tum.de', 'phone': '+49 89 4140 2251'}, {'name': 'Stefan von Delius, MD', 'role': 'CONTACT', 'email': 'stefan_ruckert@yahoo.de', 'phone': '+49 89 4140 5973'}, {'name': 'Peter Klare, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stefan von Delius, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Peter Klare, MD', 'role': 'CONTACT', 'email': 'peter.klare@lrz.tum.de', 'phone': '+49 89 4140 2251'}, {'name': 'Stefan von Delius, MD', 'role': 'CONTACT', 'email': 'stefan_ruckert@yahoo.de', 'phone': '+49 89 4140 5975'}], 'overallOfficials': [{'name': 'Stefan von Delius, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Peter Klare', 'investigatorFullName': 'Dr. Peter Klare', 'investigatorAffiliation': 'Technical University of Munich'}}}}