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