An observational study in Subepithelial Gastrointestinal Tumors and Adenoma, sponsored by Ovesco Endoscopy AG. Recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Ovesco Endoscopy AG · Observational
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.
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 conducted within the study. For data processing, an EDC system is used.
There are no patient reported outcomes, only physician-entered data on baseline, intervention/procedure, complications/adverse events and follow-up visits.
Automatic plausibility checks have been programmed for quality assurance. Furthermore, warnings and hints will be given on predefined entries not allowed or to double-check values out of normal ranges. No source data verification is planned but data management will check the entries for completeness.
No coding according to MEDRA or similar systems is planned. As the procedure is not part of the study, every participating site must operate according to their own SOPs. The sponsor and CRO have SOPs in place for conducting a study. Furthermore, data protection requirements and all applicable regulations are followed.
The sample size was calculated based results of peer-reviewed publications on the gdFTRD System. As only continuous and categorial variables will be assessed, no separate statistical analysis plan is planned. In case the collected data allows for exploratory post hoc subgroup analysis further tests can be done according to the descriptions in the protocol. Missing data will not be included in the analysis and shall not be imputed.
182 studies on the registry are indexed under Adenoma; 28 are open to participants now.
This study's planned enrollment of 306 is below the median of 600 across 51 observational studies indexed under Adenoma.
Browse Adenoma studies →Ovesco Endoscopy AG is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients of legal age in whom the gdFTRD was used for treatment independently from the registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients of legal age in whom the gdFTRD was used for treatment independently from the registry
Other: 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.
Technical success
Technical success (i.e. target lesion reached and resected; macroscopically complete)
Time frame: Directly post-procedure
Full thickness resection
Full-thickness resection (i.e. histologically confirmed full-thickness resection)
Time frame: Up to 14 days post-procedure
R0 resection
R0 resection (i.e. histologically complete lesion resection)
Time frame: Up to 14 days post-procedure
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-procedure
Incidence of procedure-related adverse events (Safety)
Total procedure-related adverse events
Time frame: Intra-procedural and directly post-procedure
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-procedure
Incidence of post-interventional complications (Safety)
Post-interventional complications
Time frame: up to 2 weeks post-procedure
Incidence of further procedure-related complications (Safety)
Other procedure-related complications
Time frame: up to 3 years post-procedure
Plan to share: No — Anonymized data will be used for publication of all participant data.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Ovesco Endoscopy AG