Condition: Colorectal Polyps · Sponsor: i+Med S.Coop.
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 adherenc…
This description comes directly from the study's public registry record.
Josune Torrecilla · +34945561134 · jtorrecilla@imasmed.com
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT07448129