Multicenter, Randomized, Double-Blind Clinical Trial on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Persistence of the compound in the submucosa
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Persistence of the compound in the submucosa
时间窗: 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.
次要结局
- Effective duration of the wheal(Every 5 minutes up to 120 minutes post-injection)
- Local adverse reactions(Up to 6 months post-injection)