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Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions.

RecruitingNAAges 18 Years - anyAlli+Med S.Coop.
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In plain words

What the trial is, and whether it could suit you

The SUBMO-PIC01-2025 study evaluates whether SUBMO®, a submucosal injection hydrogel composed of high-molecular weight hyaluronic acid and methylene blue, is as effective and safe as normal saline for endoscopic resection of superficial colorectal lesions larger than 10 mm. Its primary aim is to determine non-inferiority in complete resection rates, whether en bloc or fragmented, and to assess safety through the systematic identification of serious adverse events. Secondary aims include analysing the total volume of product needed, the number of injections required, the maintenance of the submucosal cushion, the duration of the procedure, the ease of resection, the subjective evaluation of endoscopists, and the appearance of additional adverse events related to the intervention such as intraprocedural bleeding, fever, significant post-procedure pain, post-coagulation syndrome or immediat

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects \>18 years old. * Presence of a colorectal lesion larger than 10 mm, confirmed through colonoscopy. * The lesion must be considered technically resectable using either Endoscopic Mucosal Resection (RME) or Endoscopic Submucosal Dissection (DSE). * The participant must be willing and able to comply with all required study visits and procedures, according to the protocol. * The participant must understand, sign, and date the written informed consent form before undergoing any study-specific procedures. Exclusion Criteria: * Severe comorbidities according to clinical judgment, including patients classified as ASA IV or ASA V, except those ASA IV cases explicitly approved as clinically safe by the center's Anesthesiology Service (using the ASA anesthetic classification). * Patients presenting some coagulopathy that prevents safe endoscopic resection. * Lesions that are suspicious endoscopic invasive cancer. * Any medical condition that, in the investigator's opinion, could compromise patient safety or protocol adherence. * Known allergy or hypersensitivity to any component of the investigational product, including hyaluronic acid, methylene blue, or any excipients. * Contraindications to colonoscopy or to the administration of sedation/anesthesia. * Current participation in another clinical investigation with an investigational product, or participation in any clinical study (with tested or untested products) within the previous 30 days prior to randomization. * Pregnant or breastfeeding women.
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What it tests

  • SUBMO® Submucosal Injection
  • Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection
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Where

4 sites
Hospital Universitario de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Althaia
Manresa, Spain
Hospital Universitario Basurto
Bilbao, Spain
Hospital de Cruces
Bilbao, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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