Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT07142902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of procedure-related adverse events (Safety)', 'timeFrame': 'Intra-procedural and directly post-procedure', 'description': 'Total procedure-related adverse events'}, {'measure': 'Incidence of surgery due to procedure-related adverse events (Safety)', 'timeFrame': 'up to 2 weeks post-procedure', 'description': 'Surgery due to a procedure-related adverse event'}, {'measure': 'Incidence of post-interventional complications (Safety)', 'timeFrame': 'up to 2 weeks post-procedure', 'description': 'Post-interventional complications'}, {'measure': 'Incidence of further procedure-related complications (Safety)', 'timeFrame': 'up to 3 years post-procedure', 'description': 'Other procedure-related complications'}], 'primaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Directly post-procedure', 'description': 'Technical success (i.e. target lesion reached and resected; macroscopically complete)'}], 'secondaryOutcomes': [{'measure': 'Full thickness resection', 'timeFrame': 'Up to 14 days post-procedure', 'description': 'Full-thickness resection (i.e. histologically confirmed full-thickness resection)'}, {'measure': 'R0 resection', 'timeFrame': 'Up to 14 days post-procedure', 'description': 'R0 resection (i.e. histologically complete lesion resection)'}, {'measure': 'Rate of curative resection (in case of malignant tumors)', 'timeFrame': 'Up to 14 days post-procedure', 'description': 'Rate of curative resection (in case of malignant tumors)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gdFTRD', 'gastroduodenal full thickness resection', 'endoscopic full thickness resection', 'EFTR'], 'conditions': ['Subepithelial Gastrointestinal Tumors', 'Adenoma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Exposed versus nonexposed endoscopic full-thickness resection for duodenal subepithelial lesions: a tertiary care center experience (with videos) Nabi, Zaheer et al. iGIE, Volume 2, Issue 2, 154 - 160.e2'}, {'pmid': '33015330', 'type': 'BACKGROUND', 'citation': 'Hajifathalian K, Ichkhanian Y, Dawod Q, Meining A, Schmidt A, Glaser N, Vosoughi K, Diehl DL, Grimm IS, James T, Templeton AW, Samarasena JB, Chehade NEH, Lee JG, Chang KJ, Mizrahi M, Barawi M, Irani S, Friedland S, Korc P, Aadam AA, Al-Haddad M, Kowalski TE, Smallfield G, Ginsberg GG, Fukami N, Lajin M, Kumta NA, Tang SJ, Naga Y, Amateau SK, Kasmin F, Goetz M, Seewald S, Kumbhari V, Ngamruengphong S, Mahdev S, Mukewar S, Sampath K, Carr-Locke DL, Khashab MA, Sharaiha RZ. Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience. Endosc Int Open. 2020 Oct;8(10):E1291-E1301. doi: 10.1055/a-1216-1439. Epub 2020 Sep 22.'}, {'pmid': '40079474', 'type': 'BACKGROUND', 'citation': 'Wannhoff A, Nabi Z, Moons LMG, Haber G, Ge PS, Dertmann T, Deprez PH, Korcz W, Bouvette C, Mueller J, Tribonias G, Grande G, Kim JJ, Weich A, Heinrich H, Mollenkopf M, George J, Pioche M, Azzolini F, Kouladouros K, Boger P, Hayee B, Bilal M, Bastiaansen BAJ, Caca K; Upper GI FTRD Study Group. International, Multicenter Analysis of Endoscopic Full-Thickness Resection of Duodenal Neuroendocrine Tumors. Am J Gastroenterol. 2025 Dec 1;120(12):2800-2809. doi: 10.14309/ajg.0000000000003409. Epub 2025 Mar 13.'}, {'pmid': '31187233', 'type': 'BACKGROUND', 'citation': 'Meier B, Schmidt A, Glaser N, Meining A, Walter B, Wannhoff A, Riecken B, Caca K. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc. 2020 Feb;34(2):853-860. doi: 10.1007/s00464-019-06839-2. Epub 2019 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic full-thickness resection (EFTR) is a therapeutic option for the treatment of challenging lesions such as subepithelial tumors (SETs) and epithelial neoplasia extending deeper than the mucosa or associated with significant fibrosis. EFTR may offer a less invasive treatment alternative relative to surgical approaches in selected patients.\n\nThe gastroduodenal FTRD System (gdFTRD System) is an instrument for endoscopic full-thickness resection or deep partial wall resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.\n\nThe prospectively generated data of the gdFTRD registry shall be used to evaluate the application of the gdFTRD in clinical routine, to verify the acceptability of already known risks and to identify unknown risks and complications.', 'detailedDescription': 'The gdFTRD registry is a registry on cases completed with the gdFTRD System. The gdFTRD System is used for full-thickness resection but the procedure is not part of the study. Only data processing is conducted within the study. For data processing, an EDC system is used.\n\nThere are no patient reported outcomes, only physician-entered data on baseline, intervention/procedure, complications/adverse events and follow-up visits.\n\nAutomatic plausibility checks have been programmed for quality assurance. Furthermore, warnings and hints will be given on predefined entries not allowed or to double-check values out of normal ranges. No source data verification is planned but data management will check the entries for completeness.\n\nNo coding according to MEDRA or similar systems is planned. As the procedure is not part of the study, every participating site must operate according to their own SOPs. The sponsor and CRO have SOPs in place for conducting a study. Furthermore, data protection requirements and all applicable regulations are followed.\n\nThe sample size was calculated based results of peer-reviewed publications on the gdFTRD System. As only continuous and categorial variables will be assessed, no separate statistical analysis plan is planned. In case the collected data allows for exploratory post hoc subgroup analysis further tests can be done according to the descriptions in the protocol. Missing data will not be included in the analysis and shall not be imputed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of legal age in whom the gdFTRD was used for treatment independently from the registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All patients of legal age in whom the gdFTRD was used for treatment in the upper GI tract (stomach and duodenum) independently from the registry and\n* who gave informed consent to data processing\n\nExclusion criteria:\n\n* Patients aged under 18 years\n* Patients in whom the colonic FTRD, diagnostic FTRD or non-device assisted EFTR was used for treatment\n* Patients who did not give informed consent to data processing'}, 'identificationModule': {'nctId': 'NCT07142902', 'briefTitle': 'Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ovesco Endoscopy AG'}, 'officialTitle': 'Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry', 'orgStudyIdInfo': {'id': 'F-2024-112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients of legal age with given informed consent to data processing', 'description': 'All patients of legal age in whom the gdFTRD was used for treatment independently from the registry', 'interventionNames': ['Other: Data processing only, treatment is not part of the registry']}], 'interventions': [{'name': 'Data processing only, treatment is not part of the registry', 'type': 'OTHER', 'description': 'Treatment with the gdFTRD is part of the clinical routine, the registry only comprises data processing after treatment.', 'armGroupLabels': ['All patients of legal age with given informed consent to data processing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Germany', 'country': 'Germany', 'contacts': [{'name': 'Armin Küllmer, PD Dr. med.', 'role': 'CONTACT', 'email': 'armin.kuellmer@uniklinik-freiburg.de', 'phone': '+49 761 27025416'}, {'name': 'Armin Küllmer, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julius Mueller, Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Freiburg - Klinik für Innere Medizin II', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '71640', 'city': 'Ludwigsburg', 'state': 'Germany', 'country': 'Germany', 'facility': 'RKH Kliniken Ludwigsburg-Bietigheim gGmbH', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}, {'zip': '70376', 'city': 'Stuttgart', 'state': 'Germany', 'country': 'Germany', 'contacts': [{'name': 'Arthur Schmidt, Prof. Dr.', 'role': 'CONTACT', 'email': 'arthur.schmidt@rbk.de', 'phone': '+49 711 8101-2066'}, {'name': 'Arthur Schmidt, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martin Schich, Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Moritz Schiemer, Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Robert-Bosch-Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'centralContacts': [{'name': 'Bettina Stritzke', 'role': 'CONTACT', 'email': 'bettina.stritzke@ovesco.com', 'phone': '+49 707196528-174'}, {'name': 'Marc O. Schurr, Prof. Dr.', 'role': 'CONTACT', 'email': 'marc.schurr@ovesco.com', 'phone': '+49 707196528-121'}], 'overallOfficials': [{'name': 'Andreas Wannhoff, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RKH Kliniken Ludwigsburg-Bietigheim gGmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymized data will be used for publication of all participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ovesco Endoscopy AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'novineon CRO GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}