SUBMO for Submucosal Injection in Endoscopic Resection of Colorectal Polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with colorectal polyps over 10 mm will be randomly treated with SUBMO® or saline for submucosal lifting during endoscopic mucosal resection or endoscopic submucosal dissection. The study looks to show non-inferiority of SUBMO® to saline in achieving complete resection and to compare safety, injection needs, and procedure characteristics. Secondary goals include measuring total product volume, number of injections, submucosal cushion durability, procedure duration, and ease of resection, along with endoscopist assessments and possible device- or procedure-related adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de la Santa Creu i Sant Pau
  Barcelona, Barcelona, Spain Recruiting
• Hospital Althaia
  Manresa, Barcelona, Spain Recruiting
• Hospital Universitario Basurto
  Bilbao, Bizkaia, Spain Recruiting
• Hospital de Cruces
  Bilbao, Bizkaia, Spain Recruiting

Study contacts

• Principal investigator: Angel Calderón, Dr — Hospital Universitario Basurto
• Study coordinator: Josune Torrecilla
• Email: jtorrecilla@imasmed.com
• Phone: +34945561134

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.