Trials / Completed
CompletedNCT06910514
Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
Multicenter, Randomized, Double-Blind Clinical Trial on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Nakafarma S.L. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objetive of this clinical trial is to evaluate the efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions in patients undergoing endoscopic resection procedures. The main questions it aims to answer are: Does the investigational solution improve the efficacy of endoscopic mucosal resection compared to standard practice? Is the investigational solution safe for use in colonic lesion resection procedures? Researchers will compare the investigational solution (Demirex) to a standard or placebo solution to see if it improves procedural outcomes and safety profiles. Participants will undergo endoscopic mucosal resection using either the investigational solution or the comparator, and will be monitored for procedural success, safety, and any adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Mucopolysaccharide saline solution 0.9% | Injectable solution designed for submucosal elevation in endoscopic mucosal resection. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration. |
| COMBINATION_PRODUCT | Saline solution 0.9% | Control injectable solution composed of saline 0.9 %. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration. |
Timeline
- Start date
- 2021-01-18
- Primary completion
- 2022-12-23
- Completion
- 2022-12-23
- First posted
- 2025-04-04
- Last updated
- 2025-04-09
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06910514. Inclusion in this directory is not an endorsement.