Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection — NEX-ENDOHS  

Polyps Clinical Trial

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

Status Recruiting

Clinical Trial 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%.

Clinical Trial Description

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%. Study design: This is an investigator-initiated, multicentric, international, open-label, non-controlled, prospective study: - All subjects with indications undergo screening and baseline visit, - Informed consent is obtained when scheduling the ESD or EMR procedure, - ESD or EMR is performed, at the end of resection, NexpowderTM is applied on the resected field, - A follow up visit is scheduled at 4 weeks. Endpoints: - Primary: - Assess the delayed bleeding rate after ESD or EMR of ≥20mm in a selected high-risk population when using NexpowderTM at the end of the procedure. This hypothesis is that the use of NexpowderTM will reduce the rate of DB from 16% (reported rate in the literature) to less than 5% (excepted observed rate during the study). - Secondary: - Safety of NexpowderTM endoscopic hemostasis system, - Procedure duration and NexpowderTM spaying duration, - Length of stay in hospital, - Post intervention pain, - Adverse events related to the use of NexpowderTM: - Per procedural - Early (up to controlled endoscopy or at 24hours post procedure) - Late (up to 4 weeks follow-up). ;

Related Conditions & MeSH terms

• Gastro Intestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Polyps

• NCT number: NCT06096948
• Study type: Interventional
• Source: Erasme University Hospital
• Contact: Arnaud Lemmers
• Phone: +3225556559
• Email: arnaud.lemmers@hubruxelles.be
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Completion date: July 30, 2024