Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Technical success — Directly post-procedure
  Technical success (i.e. target lesion reached and resected; macroscopically complete)

Trial sites (3)