Study Stopped
According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
1 other identifier
observational
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedDecember 9, 2016
December 1, 2016
3.5 years
June 26, 2015
December 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
intraoperative
Secondary Outcomes (5)
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
Study Arms (1)
EFTR-GERDX
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.
Interventions
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.
Eligibility Criteria
Patients in which a subepithelial gastric tumor has been detected (in our hospital, other hospitals or by transferring doctor).
You may qualify if:
- presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
- age 18 years or older
- participant has given informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karel Caca, Prof. Dr.
Klinikum Ludwigsburg
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2015
First Posted
July 2, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
December 9, 2016
Record last verified: 2016-12