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

NCT ID: NCT06910514

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2022-12-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Saline solution 0.9%

Intervention Type: COMBINATION_PRODUCT

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

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

Group Type: EXPERIMENTAL

Mucopolysaccharide saline solution 0.9%

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Torrecárdenas, Almería, Spain

UNKNOWN

Sponsor Role: collaborator

Hospital Poniente, El Ejido, Almería, Spain

UNKNOWN

Sponsor Role: collaborator

Hospital Virgen del Rocío, Seville, Spain

UNKNOWN

Sponsor Role: collaborator

Hospital de Baza, Granada, Spain

UNKNOWN

Sponsor Role: collaborator

Hospital Virgen de Valme, Seville, Spain

UNKNOWN

Sponsor Role: collaborator

Quirónsalud, Málaga, Spain

UNKNOWN

Sponsor Role: collaborator

Nakafarma S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Antonio Morales Molina, PhD in Pharmacy

Role: STUDY_DIRECTOR

Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain

Jose Antonio Morales Molina, PhD in Pharmacy

Role: PRINCIPAL_INVESTIGATOR

Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain

Sergio Ángel Requejo

Role: STUDY_CHAIR

NAKAFARMA SL

Locations

Hospital Universitario Torrecárdenas

Almería, Almería, Spain

Countries

Spain

Other Identifiers

DEMI-2019-01

Identifier Type: -

Identifier Source: org_study_id