UnknownNot Applicable

Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection

Belgium, Netherlands50 participantsStarted 2023-10-15

Plain-language summary

Safety and effectiveness of a new hemostatic system to prevent delayed bleeding after endoscopic resection in a selected high-risk population (NEXPOWDER- ENDOHS). Indication: Patients with indication of endoscopy resection by endoscopic mucal resection (EMR) or endoscopic submucosal dissection (ESD) with high risk of delayed bleeding (≥5%). Hypotheses: The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.

Who can participate

Age range

18 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: * Age: ≥18 year of age at the time of informed consent, * Patients must have given written informed consent, * Subjects with documented lesions with indication of upper or lower endoscopic removal by ESD or EMR with high risk of delayed bleeding (+/-16%), namely: * All patients under anticoagulation (vitamin K antagonist, direct anticoagulant, non-fractionated heparin or low molecular weight heparin) or anti-aggregating (P2Y12 receptor antagonists), * Patients without anticoagulation or anti-aggregating with indication of duodenal EMR or ESD (if duodenal cold snare EMR: only under anticoagulant or P2Y12 receptor antagonist), * Resection field of ESD or EMR is ≥ 20mm (same size restriction in case of endoscopic papillectomy). Exclusion Criteria: * Resection bed \<20mm, * Subject currently enrolled in another interventional confounding research (no contra-indication for image or blood collection in another protocol), * Incapacitated subjects, pregnant or lactating women.

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.

What they're measuring

Safety in terms of Adverse Events (AE related to Nexpowder)

Timeframe: 1 month

Efficacy of Nexpowder in changing the delayed bleeding rate

Timeframe: 1 month

Trial details

NCT IDNCT06096948

SponsorErasme University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

Contact for this trial

Arnaud Lemmers

+3225556559 arnaud.lemmers@hubruxelles.be

View on ClinicalTrials.gov More Gastro Intestinal Bleeding trials