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Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
Sponsor: Ovesco Endoscopy AG
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
306
Start Date
2025-08
Completion Date
2030-08
Last Updated
2025-08-27
Healthy Volunteers
No
Interventions
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.
Locations (3)
Universitätsklinikum Freiburg - Klinik für Innere Medizin II
Freiburg im Breisgau, Germany, Germany
RKH Kliniken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, Germany, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany, Germany