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

Официальное название

Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Use of a Medical Device (SUBMO®) for Submucosal Injection in Endoscopic Resection Techniques of Superficial Gastrointestinal Lesions.

Обзор

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 immediate or delayed perforation. Eligible participants are adults aged 18 or older with a confirmed colorectal lesion greater than 10 mm that is technically resectable using EMR or ESD, who are capable and willing to follow the study procedures and who have signed informed consent prior to any protocol-specific action. Exclusion criteria include severe comorbidities corresponding to ASA IV or V unless specifically authorised by anaesthesia, coagulopathies that prevent endoscopic resection, endoscopic suspicion of invasive cancer, any condition deemed by investigators to compromise safety or adherence, known allergy to hyaluronic acid, methylene blue or excipients, contraindications to colonoscopy or sedation, participation in another clinical investigation within the previous 30 days, and pregnancy or breastfeeding. Participants may be withdrawn due to voluntary consent withdrawal, safety concerns, protocol deviations that affect data integrity or patient safety, loss to follow-up or pregnancy discovered during the study. The main efficacy variable is the technical success of resection as judged immediately by the endoscopist, while the main safety variable is the incidence of serious adverse events and their causal relationship with the investigational product. Exploratory variables include baseline demographics such as age, sex, ethnic origin and body mass index, anticoagulant or antiplatelet medication, and comorbidities including endoscopic history, obesity, hypertension, cardiovascular disease, haematologic disorders such as von Willebrand disease or haemophilia, and chronic liver disease. Baseline variables also include ASA classification and lifestyle habits. Polyp-related variables include size, number, anatomical location in the colon or rectum, LST subtype and JNET classification. Resection-related variables capture the technique used (EMR or ESD), whether the resection is en bloc or piecemeal, the number of fragments for calculating the Sydney Resection Quotient, the DMI score and any closure technique or complications. Treatment-related variables include total and per-surface area injection volume, number of submucosal injections needed, macroscopic evaluation of cushion maintenance, total procedure time, ease of resection using a visual analogue scale from 0 to 100, a usability questionnaire completed by the endoscopists and a detailed record of all adverse events including bleeding, fever, pain, post-coagulation syndrome and perforation.

Вмешательства

• Устройство SUBMO® Submucosal Injection
  Participants randomized to this arm undergo endoscopic resection (EMR or ESD) in which the submucosal injection is performed using SUBMO®, a high-viscosity hydrogel composed of high-molecular-weight hyaluronic acid and methylene blue. SUBMO® is administered through a standard injection needle to create and maintain a stable submucosal cushion that facilitates safe and complete resection of colorectal lesions. Its integrated dye enhances visualization of the submucosal layer. All other aspects of
• Устройство Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection
  Participants in this arm undergo endoscopic resection using normal saline as the submucosal injection solution, combined with surface dye staining (methylene blue or indigo carmine) prepared as customary in hospital practice, ensuring visibility equivalent to that of the experimental product. Saline is injected to raise the mucosa and allow resection, following standard EMR or ESD clinical techniques. This arm represents the current standard of care for submucosal injection in colorectal lesion

Первичные конечные точки

• Resection (RME / ESD) Technical Success [Срок оценки: Immediatly after procedure (day 0)]
• Incidence and Characterisation of Serious Adverse Events (SAEs) [Срок оценки: Throughout the study (from day 0 to 1 month)]

Вторичные конечные точки (11)

• Total size of the lesion (mm) [Срок оценки: During intervention (day 0)]
• Number of lesions (>10 mm) [Срок оценки: During intervention (day 0)]
• Anatomical location of the lesion [Срок оценки: During intervention (day 0)]
• LST (Lateral Spreading Tumor) classification [Срок оценки: During intervention (day 0)]
• JNET (Japanese NBI Expert Team) classification [Срок оценки: During intervention (day 0)]
• Resection Technique [Срок оценки: During intervention (Day 0)]
• Analysis of lesion removal (single piece removal vs. multiple fragments removal) [Срок оценки: During intervention (Day 0)]
• Number of Fragments collected [Срок оценки: During intervention (Day 0)]
• Sydney Deep Mural Injury Score (DMI) [Срок оценки: During intervention (Day 0)]
• Closure Techniques vs. Hemostatic measures [Срок оценки: During intervention (Day 0)]
• Intra-procedural complications [Срок оценки: During intervention (Day 0)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 4 центра

• Hospital Universitario de la Santa Creu i Sant Pau — Barcelona
• Hospital Althaia — Manresa
• Hospital Universitario Basurto — Bilbao
• Hospital de Cruces — Bilbao

Идентификаторы

NCT: NCT07448129 · SUBMO-PIC01-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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