Clinical trial · Observational
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial
NCT02362126CI-TRIAL-00016843WALL-RESECTunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.
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 |
|---|---|---|---|
| Colorectal Adenomas | — | UNRESOLVED | — |
| Submucosal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic full thickness resection (EFTR) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing EFTR
- description
- Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors
- interventionNames
- Device: Endoscopic full thickness resection (EFTR)
Primary outcomes (2)
- measure
- Technical success
- timeFrame
- Immediate
- description
- Successful enbloc- and macroscopically complete resection
- measure
- R0-Resection
- timeFrame
- 3 days
- description
- Histologically confirmed complete resection
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 y * Adenoma with negtive lifting sign * Adenoma involving or next to a diverticulum * Adenoma involving or next to the appendical orifice * T1 carcinoma with indication for endoscopic (re-)resection * Subepithelial colorectal tumor with indication for resection Exclusion Criteria: * Lesions \>3 cm * T1 carcinomas with known high-risk features (submucosal infiltration\>1000 um, invasion of lymphatic vessels, poor differentiation (G3)) * Lesions in the upper GI tract * Patients with colorectal stenosis * Patinets not able to undergo informed consent * Pregnancy * Patients with urgent indication for dual thrombocyte aggregation inhibition
References
Publications (4)
- BACKGROUNDSchurr MO, Baur FE, Krautwald M, Fehlker M, Wehrmann M, Gottwald T, Prosst RL. Endoscopic full-thickness resection and clip defect closure in the colon with the new FTRD system: experimental study. Surg Endosc. 2015 Aug;29(8):2434-41. doi: 10.1007/s00464-014-3923-x. Epub 2014 Oct 16. PMID 25318369
- BACKGROUNDSchmidt A, Damm M, Caca K. Endoscopic full-thickness resection using a novel over-the-scope device. Gastroenterology. 2014 Oct;147(4):740-742.e2. doi: 10.1053/j.gastro.2014.07.045. Epub 2014 Jul 30. No abstract available. PMID 25083605
- DERIVEDKuellmer A, Behn J, Beyna T, Schumacher B, Meining A, Messmann H, Neuhaus H, Albers D, Birk M, Probst A, Faehndrich M, Frieling T, Goetz M, Thimme R, Caca K, Schmidt A. Endoscopic full-thickness resection and its treatment alternatives in difficult-to-treat lesions of the lower gastrointestinal tract: a cost-effectiveness analysis. BMJ Open Gastroenterol. 2020 Aug;7(1):e000449. doi: 10.1136/bmjgast-2020-000449. PMID 32816955
- DERIVEDSchmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10. PMID 28798042