Clinical Trial

Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07142902
Lead Sponsor Ovesco Endoscopy AG
Collaborators: novineon CRO GmbH
Conditions Subepithelial Gastrointestinal Tumors, Adenoma
Enrollment 306 participants
Start Date 2025-08
Primary Completion 2030-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2025-08-27