NCT06096948

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Detailed 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).

Conditions

• Gastro Intestinal Bleeding
• Polyps

Interventions

Type	Name	Description
DEVICE	NEXPOWDER-ENDOHS	Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-04-30
• Completion: 2024-07-30
• First posted: 2023-10-24
• Last updated: 2023-10-24

Locations

12 sites across 2 countries: Belgium, Netherlands