NCT03096236

Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.

Conditions

• Feasibility, Complications

Interventions

Type	Name	Description
DEVICE	EFTR	EFTR with the FTRD developed for gastric resection (gFTRD).

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-01
• Completion: 2019-09-01
• First posted: 2017-03-30
• Last updated: 2017-09-18

Locations

1 site across 1 country: Germany