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

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 Overview

• Status: Completed
• Conditions: Colonic Neoplasms; Treatment Outcome; Endoscopic Mucosal Resection; Therapeutic Irrigation
• Intervention / Treatment: Combination product: Saline solution 0.9%; Combination product: Mucopolysaccharide saline solution 0.9%

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain, 04009
    • Hospital Universitario Torrecárdenas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEMIREX; 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	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.
Placebo Comparator: Saline solution 0.9%; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From administration up to 120 minutes post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 6 months post-injection

Collaborators and Investigators

• Sponsor: Nakafarma S.L.
• Collaborators: Hospital Torrecárdenas, Almería, Spain; Hospital Poniente, El Ejido, Almería, Spain; Hospital Virgen del Rocío, Seville, Spain; Hospital de Baza, Granada, Spain; Hospital Virgen de Valme, Seville, Spain; Quirónsalud, Málaga, Spain
• Investigators: Study Director: Jose Antonio Morales Molina, PhD in Pharmacy, Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain; Principal Investigator: Jose Antonio Morales Molina, PhD in Pharmacy, Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain; Study Chair: Sergio Ángel Requejo, NAKAFARMA SL

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: DEMIREX
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Pharmaceutical Solutions
• Other Study ID Numbers: DEMI-2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No