Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOvesco Endoscopy AG
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Data processing only, treatment is not part of the registry
Treatment groups
306 Participants
are divided into 1 treatment groupSponsors and collaborators
Ovesco Endoscopy AG
Lead sponsor
novineon CRO GmbH
Collaborator
Source ClinicalTrials.gov