Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry

NCT07142902 | Not Yet Recruiting

• 1 other identifier: F-2024-112
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 3

Brief Summary

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

Subepithelial Gastrointestinal Tumors; Adenoma

Keywords

gdFTRD; gastroduodenal full thickness resection; endoscopic full thickness resection; EFTR

Outcome Measures

Primary Outcomes (1)

• Technical success

  Technical success (i.e. target lesion reached and resected; macroscopically complete)

  Directly post-procedure

Secondary Outcomes (3)

• Full thickness resection

  Up to 14 days post-procedure

• R0 resection

  Up to 14 days post-procedure

• Rate of curative resection (in case of malignant tumors)

  Up to 14 days post-procedure

Other Outcomes (4)

• Incidence of procedure-related adverse events (Safety)

  Intra-procedural and directly post-procedure

• Incidence of surgery due to procedure-related adverse events (Safety)

  up to 2 weeks post-procedure

• Incidence of post-interventional complications (Safety)

  up to 2 weeks post-procedure

Study Arms (1)

All patients of legal age with given informed consent to data processing

All patients of legal age in whom the gdFTRD was used for treatment independently from the registry

Other: Data processing only, treatment is not part of the registry

Interventions

Data processing only, treatment is not part of the registry OTHER

Treatment with the gdFTRD is part of the clinical routine, the registry only comprises data processing after treatment.

All patients of legal age with given informed consent to data processing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients of legal age in whom the gdFTRD was used for treatment independently from the registry.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ovesco Endoscopy AG: lead
• novineon CRO GmbH: collaborator

Study Sites (3)

Universitätsklinikum Freiburg - Klinik für Innere Medizin II

Freiburg im Breisgau, Germany, 79106, Germany

Location

RKH Kliniken Ludwigsburg-Bietigheim gGmbH

Ludwigsburg, Germany, 71640, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, Germany, 70376, Germany

Location

Related Publications (4)

• 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

  BACKGROUND

• 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: 33015330 BACKGROUND

• 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: 40079474 BACKGROUND

• 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.

  PMID: 31187233 BACKGROUND

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Andreas Wannhoff, PD Dr. med.

  RKH Kliniken Ludwigsburg-Bietigheim gGmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bettina Stritzke

CONTACT

+49 707196528-174; bettina.stritzke@ovesco.com

Marc O. Schurr, Prof. Dr.

CONTACT

+49 707196528-121; marc.schurr@ovesco.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 27, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)