Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02488746
• Other study ID #: FROST
• Status: Terminated
• Phase: N/A
• First received: June 26, 2015
• Last updated: December 8, 2016
• Start date: March 2015
• Est. completion date: September 2018

Study information

• Verified date: December 2016
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Federal Institute for Drugs and Medicinal Devices GERMANY:
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Neoplasms
• Gastrointestinal Stromal Tumors
• Stomach Neoplasms

Intervention

Device:
• GERDX(TM)
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved		intraoperative	No
Secondary	Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved		within one week after resection (as soon as result of pathologic analysis of resected specimen is available)	No
Secondary	Rate of complications (bleeding, perforation)		6 months after resection	Yes
Secondary	Duration of hospitalization		within one week after resection	No
Secondary	Number of participants with local or systemic recidive of tumor		6 months after resection	No
Secondary	Number of participants with needs of surgical therapy or endoscopic re-resection		6 months after resection	No