Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection (NEX-ENDOHS)

October 20, 2023 updated by: Lemmers Arnaud, Erasme University Hospital

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

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%.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussel, Belgium, 1000
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc (UCL)
        • Contact:
      • Brussels, Belgium, 1070
        • Recruiting
        • HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)
        • Sub-Investigator:
          • Vincent Huberty, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arnaud Lemmers, MD,PhD
        • Sub-Investigator:
          • Jacques Devière, MD,PhD
        • Sub-Investigator:
          • Marianna Arvanitakis, MD, PhD
        • Sub-Investigator:
          • Michael Fernandez, MD, PhD
        • Sub-Investigator:
          • Sohaib Ouazzani, MD, PhD
        • Sub-Investigator:
          • Ana-Maria Bucalau, MD, PhD
        • Sub-Investigator:
          • Julia Chaves Rodriguez, MD
        • Sub-Investigator:
          • Pierre Eisendrath, MD, PhD
        • Sub-Investigator:
          • Mariana Figueiredo, MD
      • Gent, Belgium, 9000
      • Liège, Belgium, 4000
    • Oost-Vlaanderen
    • Vlaams Brabant
    • West-Vlaanderen
  • Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEXPOWDER-ENDOHS
Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.
Device: NEXPOWDER-ENDOHS
Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety in terms of Adverse Events (AE related to Nexpowder)
Time Frame: 1 month
  • number of intraprocedural complications (perforation,…)
  • number of post-procedure complications (delayed perforation, peritonitis,..)
1 month
Efficacy of Nexpowder in changing the delayed bleeding rate
Time Frame: 1 month
Decrease the delayed bleeding rate
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEXPOWDER-ENDOHS
  • P2023/250 (Other Identifier: ERASME ETHICS COMMITTEE)
  • B4062023000141 (Other Identifier: ERASME ETHICS COMMITTEE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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