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

April 7, 2025 updated by: Nakafarma S.L.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From administration up to 120 minutes post-injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Every 5 minutes up to 120 minutes post-injection
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.
Up to 6 months post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nakafarma S.L.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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