Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions

Nakafarma S.L.

Status and phase: Completed; Phase 3

Conditions: Colonic Neoplasms; Endoscopic Mucosal Resection; Treatment Outcome; Therapeutic Irrigation

Treatments: Combination Product: Mucopolysaccharide saline solution 0.9%; Combination Product: Saline solution 0.9%

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06910514

DEMI-2019-01

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of any sex, >18 years old, diagnosed with sessile or flat polyps, with a diameter greater than or equal to 2 cm, in the intestinal submucosa by the Endoscopy Unit.
• The subject has understood and signed an informed consent form (ICF) approved by a Research Ethics Committee (REC) before any study evaluation and commits to completing the study as defined in the protocol.
• Not undergoing active treatment with antiplatelet or anticoagulant drugs.
• After signing the informed consent, patients are scheduled for lesion resection within <3 months from their diagnosis.

Exclusion criteria

• Patients with documented allergy to any of the components of the mucosectomy solution or drugs used in sedation.
• Pregnant women.
• Patients on contraceptive treatment or post-menopausal.
• Hematological disorders with uncorrected coagulation abnormalities, with an INR >= 1.5, or patients undergoing active treatment with antiplatelet or anticoagulant drugs.
• Patients with intestinal perforation or obstruction, toxic megacolon, diverticulitis, or inflammatory bowel disease.
• Patients with previous partial resection or pending resection.
• Patients with lesions classified as Paris type III and/or invasive intestinal carcinoma and/or metastases. Patients with previous treatment of the lesion (radiotherapy, endoscopic, surgical, chemotherapy).
• Patients included in another study during the previous month.
• Conditions that, in the medical judgment, contraindicate polyp removal.
• Absence of a signed informed consent, non-acceptance, or contraindication of surgical or anesthetic techniques (Patients with ASA status: High anesthetic risk (ASA score > 3)) and difficulty in the patient's understanding of the conditions of the endoscopic procedure.
• Endoscopic appearance of invasive malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Saline solution 0.9%

Placebo Comparator group

Description:

This arm of the study serves as the placebo comparator, where participants will receive a sterile saline solution administered under the same conditions as the experimental treatment. The saline solution does not contain the active ingredient being studied and will be used to evaluate the efficacy and safety of the experimental treatment in comparison to the control group.

Treatment:

Combination Product: Saline solution 0.9%

DEMIREX

Experimental group

Description:

This arm of the study serves as the experimental treatment group, where participants will receive a study solution administered under conditions intended to facilitate endoscopic mucosal resection of colonic lesions. This experimental arm aims to evaluate the efficacy and safety of this novel solution (Demirex) for the endoscopic resection of mucosal lesions in the colon with a diameter of ≥2 cm

Treatment:

Combination Product: Mucopolysaccharide saline solution 0.9%