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Multicenter, Randomized, Double-Blind Clinical Trial on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Torrecárdenas
Almería, Almería, Spain
Start Date
January 18, 2021
Primary Completion Date
December 23, 2022
Completion Date
December 23, 2022
Last Updated
April 9, 2025
52
ACTUAL participants
Mucopolysaccharide saline solution 0.9%
COMBINATION_PRODUCT
Saline solution 0.9%
COMBINATION_PRODUCT
Lead Sponsor
Nakafarma S.L.
Collaborators
NCT06885697
NCT05789433
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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