Clinical trial · Interventional
Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract
NCT02688699CI-TRIAL-00066444unknownPhase 4ClinicalTrials.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)
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions \>20 mm in the right colon
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Dysplasia | — | UNRESOLVED | — |
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Colonic Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoClot | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EndoClot
- description
- spraying of Endoclot powder after EMR or ESD
- interventionNames
- Procedure: EndoClot
- type
- NO_INTERVENTION
- label
- control
Primary outcomes (1)
- measure
- effectiveness of EndoClotTM in preventing post-procedural bleeding
- timeFrame
- 14 days
- description
- The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions \>20 mm in the right colon
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>18 years old * lesions suitable for EMR or ESD * \> 20 mm * site in the right colon Exclusion Criteria: * Severe cardiovascular pathologies * Liver and Urinary dysfunctions * Hematologic diseases * Pregnancy and breast feeding * impossible follow-up * platelet and coagulation disorders (PLT \< 50 x 109/L, INR \> 2) * Sensitivity or allergy to the drug
References
Publications (0)
Data not yet available
No reference posted for this study.