Clinical trial · Observational
Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The 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. The 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Subepithelial Gastrointestinal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data processing only, treatment is not part of the registry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- measure
- Technical success
- timeFrame
- Directly post-procedure
- description
- Technical success (i.e. target lesion reached and resected; macroscopically complete)
Secondary outcomes (3)
- measure
- Full thickness resection
- timeFrame
- Up to 14 days post-procedure
- description
- Full-thickness resection (i.e. histologically confirmed full-thickness resection)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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 * who gave informed consent to data processing Exclusion criteria: * Patients aged under 18 years * Patients in whom the colonic FTRD, diagnostic FTRD or non-device assisted EFTR was used for treatment * Patients who did not give informed consent to data processing
References
Publications (4)
- BACKGROUNDNabi Z, Basha J, Inavolu P, Sayyed M, Ramchandani M, Goud R, Darisetty S, Kotla R, Reddy DN. Exposed versus nonexposed endoscopic full-thickness resection for duodenal subepithelial lesions: a tertiary care center experience (with videos). IGIE. 2023 May 19;2(2):154-160.e2. doi: 10.1016/j.igie.2023.04.004. eCollection 2023 Jun. PMID 41647622
- BACKGROUNDHajifathalian 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 33015330
- BACKGROUNDWannhoff 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 40079474
- BACKGROUNDMeier 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. PMID 31187233