Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02488746

Enrollment

Registered

2015-07-02

Start date

2015-03-31

Completion date

2018-09-30

Last updated

2016-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Neoplasms, Gastrointestinal Stromal Tumors

Brief 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.

Interventions

DEVICEGERDX(TM)

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved	intraoperative

Secondary

Measure	Time frame
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)
Rate of complications (bleeding, perforation)	6 months after resection
Duration of hospitalization	within one week after resection
Number of participants with local or systemic recidive of tumor	6 months after resection
Number of participants with needs of surgical therapy or endoscopic re-resection	6 months after resection

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026