Status:
NOT_YET_RECRUITING
Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
Lead Sponsor:
Ovesco Endoscopy AG
Collaborating Sponsors:
novineon CRO GmbH
Conditions:
Subepithelial Gastrointestinal Tumors
Adenoma
Eligibility:
All Genders
18+ years
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 mucos...
Detailed Description
The gdFTRD registry is a registry on cases completed with the gdFTRD System. The gdFTRD System is used for full-thickness resection but the procedure is not part of the study. Only data processing is ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT07142902
Start Date
August 1 2025
End Date
August 1 2030
Last Update
August 27 2025
Active Locations (3)
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1
Universitätsklinikum Freiburg - Klinik für Innere Medizin II
Freiburg im Breisgau, Germany, Germany, 79106
2
RKH Kliniken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, Germany, Germany, 71640
3
Robert-Bosch-Krankenhaus
Stuttgart, Germany, Germany, 70376