Colonic Neoplasms, Endoscopic Mucosal Resection, Therapeutic Irrigation, Treatment Outcome
Conditions
Keywords
DEMIREX
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.
Interventions
COMBINATION_PRODUCTMucopolysaccharide 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_PRODUCTSaline 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
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
Nakafarma S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of the compound in the submucosa | 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
| Measure | Time frame | Description |
|---|---|---|
| Effective duration of the wheal | 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. |
| Local adverse reactions | 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. |
Countries
Spain
Outcome results
None listed