Status:
COMPLETED
Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
Lead Sponsor:
Nakafarma S.L.
Collaborating Sponsors:
Hospital Torrecárdenas, Almería, Spain
Hospital Poniente, El Ejido, Almería, Spain
Conditions:
Endoscopic Mucosal Resection
Colonic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06910514
Start Date
January 18 2021
End Date
December 23 2022
Last Update
April 9 2025
Active Locations (1)
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1
Hospital Universitario Torrecárdenas
Almería, Almería, Spain, 04009