Skip to main content
OpenTrials
Completed

NCT Number: NCT06910514

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endoscopic Mucosal Resection Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Therapeutic Irrigation Treatment Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Torrecárdenas

Almería, 04009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Persistence of the compound in the submucosa

    Time frame: From administration up to 120 minutes post-injection

    Duration for which the injected compound remains visible in the submucosa, assessed through clinical observation and imaging techniques.

Secondary outcomes

  1. Effective duration of the wheal

    Time frame: Every 5 minutes up to 120 minutes post-injection

    Time in minutes during which the wheal remains visible and measurable after the compound injection, assessed using a digital caliper.

  2. Local adverse reactions

    Time frame: Up to 6 months post-injection

    Number of participants experiencing local adverse reactions, evaluated through clinical inspection and classified according to the CTCAE v4.0 scale.

Sponsors and collaborators

Lead sponsor

Nakafarma S.L.

Industry

Collaborators

  • Hospital Poniente, El Ejido, Almería, Spain
  • Hospital Torrecárdenas, Almería, Spain
  • Hospital Virgen de Valme, Seville, Spain
  • Hospital de Baza, Granada, Spain
  • Hospitales Universitarios Virgen del Rocío
  • Quirónsalud, Málaga, Spain

Registry information

Official study title

Multicenter, Randomized, Double-Blind Clinical Trial on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.