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

NCT06910514 | Completed Phase 3 DMC

• 1 other identifier: DEMI-2019-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

DEMIREX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effective duration of the wheal

  Every 5 minutes up to 120 minutes post-injection

• Local adverse reactions

  Up to 6 months post-injection

Study Arms (2)

Saline solution 0.9%

PLACEBO COMPARATOR

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%

DEMIREX

EXPERIMENTAL

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%

Interventions

Mucopolysaccharide saline solution 0.9% COMBINATION_PRODUCT

Injectable solution designed for submucosal elevation in endoscopic mucosal resection. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration.

DEMIREX

Saline solution 0.9% COMBINATION_PRODUCT

Control injectable solution composed of saline 0.9 %. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration.

Saline solution 0.9%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nakafarma S.L.: lead
• Hospital Torrecárdenas, Almería, Spain: collaborator
• Hospital Poniente, El Ejido, Almería, Spain: collaborator
• Hospital Virgen del Rocío, Seville, Spain: collaborator
• Hospital de Baza, Granada, Spain: collaborator
• Hospital Virgen de Valme, Seville, Spain: collaborator
• Quirónsalud, Málaga, Spain: collaborator

Study Sites (1)

Hospital Universitario Torrecárdenas

Almería, Almería, 04009, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jose Antonio Morales Molina, PhD in Pharmacy

  Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain

  STUDY DIRECTOR

• Jose Antonio Morales Molina, PhD in Pharmacy

  Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain

  PRINCIPAL INVESTIGATOR

• Sergio Ángel Requejo

  NAKAFARMA SL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is a double-blind, randomized clinical trial, meaning that participants and investigators are unaware of the treatment allocation. The investigational solution and the comparator (placebo or treatment) are identical in appearance, volume, and administration method to ensure blinding. Unblinding will only occur in cases of medical necessity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Double-Blind Clinical Trial with a 4:1 Allocation on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: April 4, 2025
• Study Start: January 18, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

ES (1)