Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucos… (NCT05247515) | Clinical Trial Compass
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Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection
France304 participantsStarted 2022-07-01
Plain-language summary
Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* More than 18 years old
* Indication of EMR for a superficial nonpedunculated colorectal lesion
* Higher risk of bleeding (score GSEED RE2 ≥ 7\*)
\*Score GSEED RE2 (Albeniz et al GIE 2020):
* Proximal location (cecum to transverse included) : 3 points
* Antiplatelets or anticoagulation use: 3 points
* Lesion size ≥ 40 mm: 1 point
* ASA III-IV or major comorbidity: 1 point
Exclusion Criteria:
* Patients susceptible to allergic reactions to certain substances in Nexpowder
* More than one colorectal lesion
* Suspicion of invasive cancer (Kudo V, Sano IIIb, Connect III), macronodular more than 1 cm, depressed area (Paris IIc)
* Pedunculated polyps (Ip from Paris classification) or ulcerated polyps (III)
* Recurrent or residual lesion after endoscopic or surgical resection
* Poor bowel preparation quality (Boston score \< 6)
* Inflammatory bowel disease (IBD)
* Patients with a platelet count of 50,000/mm3 or less
* Patients with acquired (non-medicated) or inherited bleeding disorders
* Patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement)
* Contraindication to general anesthesia
* Women who are pregnant or who wish to become pregnant during the study or women who are breastfeeding.
* Children, immunocompromised persons and persons over 90 years of age
* Patients already participating or scheduled to participate in other clinical trials
* Lesion previously resected by endoscopy
* Patient with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.