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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Injectable solution designed for submucosal elevation in endoscopic mucosal resection. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration.
Control injectable solution composed of saline 0.9 %. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration.
Hospital Universitario Torrecárdenas
Almería, Almería, Spain
Persistence of the compound in the submucosa
Duration for which the injected compound remains visible in the submucosa, assessed through clinical observation and imaging techniques.
Time frame: From administration up to 120 minutes post-injection
Effective duration of the wheal
Time in minutes during which the wheal remains visible and measurable after the compound injection, assessed using a digital caliper.
Time frame: Every 5 minutes up to 120 minutes post-injection
Local adverse reactions
Number of participants experiencing local adverse reactions, evaluated through clinical inspection and classified according to the CTCAE v4.0 scale.
Time frame: Up to 6 months post-injection
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