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

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

Interventions

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.

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.

Sponsors & Collaborators

• Hospital Torrecárdenas, Almería, Spain

  collaborator UNKNOWN

• Hospital Poniente, El Ejido, Almería, Spain

  collaborator UNKNOWN

• Hospital Virgen del Rocío, Seville, Spain

  collaborator UNKNOWN

• Hospital de Baza, Granada, Spain

  collaborator UNKNOWN

• Hospital Virgen de Valme, Seville, Spain

  collaborator UNKNOWN

• Quirónsalud, Málaga, Spain

  collaborator UNKNOWN

• Nakafarma S.L.

  lead INDUSTRY

Principal Investigators

• Jose Antonio Morales Molina, PhD in Pharmacy · Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain

• Jose Antonio Morales Molina, PhD in Pharmacy · Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain

• Sergio Ángel Requejo · NAKAFARMA SL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-18

Primary Completion

2022-12-23

Completion

2022-12-23

Countries

• Spain

Study Locations