Clinical trial · Observational
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
NCT02488746CI-TRIAL-00025096terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Neoplasms | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GERDX(TM) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EFTR-GERDX
- description
- Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.
- interventionNames
- Device: GERDX(TM)
Primary outcomes (1)
- measure
- Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
- timeFrame
- intraoperative
Secondary outcomes (5)
- measure
- Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved
- timeFrame
- within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
- measure
- Rate of complications (bleeding, perforation)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.