TerminatedNot Applicable

Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Stopped: According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.

Germany5 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: intraoperative

Trial details

NCT IDNCT02488746

SponsorKliniken Ludwigsburg-Bietigheim gGmbH

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-09

View on ClinicalTrials.gov More Gastric Neoplasms trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.