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Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry

NCT07142902 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 306

Last updated 2025-08-27

No results posted yet for this study

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

Interventions

OTHER

Data processing only, treatment is not part of the registry

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

Sponsors & Collaborators

  • novineon CRO GmbH

    collaborator UNKNOWN

  • Ovesco Endoscopy AG

    lead INDUSTRY

Principal Investigators

  • Andreas Wannhoff, PD Dr. med. · RKH Kliniken Ludwigsburg-Bietigheim gGmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2030-08-31
Completion
2030-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07142902 on ClinicalTrials.gov