Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Kliniken Ludwigsburg-Bietigheim gGmbH

Status: Terminated

Conditions: Gastrointestinal Stromal Tumors; Gastric Neoplasms

Treatments: Device: GERDX(TM)

Study type: Observational

Funder types: Other

Identifiers

NCT02488746

FROST

Details and patient eligibility

About

Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
• age 18 years or older
• participant has given informed consent

Exclusion criteria

• tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass
• signs of systemic dissemination of tumor
• current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
• former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
• moribund patient
• limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
• pregnancy and lactation period

Trial design

5 participants in 1 patient group

EFTR-GERDX

Description:

Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.

Treatment:

Device: GERDX(TM)