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
This trial does not accept healthy volunteersQualifiers
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 population
All patients of legal age in whom the gdFTRD was used for treatment independently from the registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data processing only, treatment is not part of the registry
Other interventionTreatment with the gdFTRD is part of the clinical routine, the registry only comprises data processing after treatment.
Treatment groups
306 Participants
are divided into 1 treatment groupGroup A: All patients of legal age with given informed consent to data processing1 intervention
Trial outcomes
Primary outcomes
1
Technical success
Technical success (i.e. target lesion reached and resected; macroscopically complete)
Time frame
Directly post-procedureSecondary outcomes
1
Full thickness resection
Full-thickness resection (i.e. histologically confirmed full-thickness resection)
Time frame
Up to 14 days post-procedure2
R0 resection
R0 resection (i.e. histologically complete lesion resection)
Time frame
Up to 14 days post-procedure3
Rate of curative resection (in case of malignant tumors)
Rate of curative resection (in case of malignant tumors)
Time frame
Up to 14 days post-procedureOther outcomes
1
Incidence of procedure-related adverse events (Safety)
Total procedure-related adverse events
Time frame
Intra-procedural and directly post-procedure2
Incidence of surgery due to procedure-related adverse events (Safety)
Surgery due to a procedure-related adverse event
Time frame
up to 2 weeks post-procedure3
Incidence of post-interventional complications (Safety)
Post-interventional complications
Time frame
up to 2 weeks post-procedure4
Incidence of further procedure-related complications (Safety)
Other procedure-related complications
Time frame
up to 3 years post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ovesco Endoscopy AG
Lead sponsor
novineon CRO GmbH
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: