Clinical trial · Interventional
Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
NCT02519140CI-TRIAL-00071931withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cook Medical EMR Gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cook medical EMR Gel
- description
- Prospective study involving excised human stomachs and colon harvested from sleeve gastrectomies and colectomies performed for benign or malignant disease. Different Cook submucosal injections of varying viscosities will be injected into different areas of the excised stomachs or colons. Data collected will involve lifting characteristics and dissection adequacy of the varying viscosities of gel.
- interventionNames
- Drug: Cook Medical EMR Gel
Primary outcomes (1)
- measure
- Lift Efficacy
- timeFrame
- 1 hour
- description
- Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
Secondary outcomes (1)
- measure
- Dissection Adequacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Pts undergoing sleeve gastrectomy * Pts undergoing colectomy Exclusion Criteria: * Unable to give or understand consent * All of the excised tissue will be needed for diagnostic purposes
References
Publications (1)
- BACKGROUNDChandrasekhara V, Sigmon JC Jr, Surti VC, Kochman ML. A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. Surg Endosc. 2013 Aug;27(8):3039-42. doi: 10.1007/s00464-013-2813-y. Epub 2013 Feb 8. PMID 23392984