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Tests treatment safety and results for Colorectal Polyps
Official title Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions.
ClinicalTrials.gov ID: NCT07448129
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people \>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.
You likely can't join if
- Severe comorbidities according to clinical judgment, including patients classified as ASA IV or ASA V, except those ASA IV cases explicitly approved...
- 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.
See the full eligibility criteria
- people \>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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
- Manresa, Barcelona, Spain
- Bilbao, Bizkaia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain; Manresa, Barcelona, Spain; Bilbao, Bizkaia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.