Using Nexpowder to prevent delayed bleeding after endoscopic resection

Safety and Efficacy of a New Hemostatic System to Prevent Delayed Bleeding After Endoscopic Resection in a Selected High-risk Population

This study is testing if using Nexpowder after certain endoscopic procedures can help prevent delayed bleeding in patients who are at high risk.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erasme University Hospital (other)
• Locations: 12 sites (Gent, Oost-Vlaanderen and 11 other locations)
• Trial ID: NCT06096948 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Nexpowder, a hemostatic system, in preventing delayed bleeding in patients undergoing endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with a high risk of bleeding. Participants will receive Nexpowder application at the end of their procedure, and their outcomes will be monitored for delayed bleeding rates and other safety measures. The study aims to reduce the incidence of delayed bleeding from the expected 16% to less than 5% in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with documented lesions requiring EMR or ESD and a high risk of delayed bleeding.

Not a fit: Patients with resection beds smaller than 20mm or those currently enrolled in other conflicting studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of delayed bleeding after endoscopic procedures, improving patient safety and outcomes.

How similar studies have performed: While the use of hemostatic agents in endoscopic procedures has been explored, this specific application of Nexpowder is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Gent, Oost-Vlaanderen and 11 other locations

• AZ Maria Middelares — Gent, Oost-Vlaanderen, Belgium (RECRUITING)
• UZ Gasthuisberg (KUL) — Leuven, Vlaams Brabant, Belgium (RECRUITING)
• AZ Sint-Jan Brugge-Oostende — Brugge, West-Vlaanderen, Belgium (RECRUITING)
• AZ Delta Campus Rumbeke — Roeselare, West-Vlaanderen, Belgium (RECRUITING)
• HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB) — Brussels, Belgium (RECRUITING)
• Cliniques universitaires Saint-Luc (UCL) — Brussels, Belgium (RECRUITING)
• CHU Saint-Pierre — Brussel, Belgium (RECRUITING)
• UZ Gent — Gent, Belgium (RECRUITING)
• Groupe Santé CHC - Clinique du MontLégia — Liège, Belgium (RECRUITING)
• Amsterdam UMC - Location VUMC — Amsterdam, Netherlands (NOT_YET_RECRUITING)
• Amsterdam UMC - Location AMC — Amsterdam, Netherlands (NOT_YET_RECRUITING)
• UMC Utrecht — Utrecht, Netherlands (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Arnaud Lemmers

Conditions: Gastro Intestinal Bleeding, Polyps