Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection

Last updated: October 20, 2023
Sponsor: Erasme University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Polyps

Gastric Ulcers

Treatment

NEXPOWDER-ENDOHS

Clinical Study ID

NCT06096948
NEXPOWDER-ENDOHS
P2023/250
B4062023000141
  • Ages > 18
  • All Genders

Study 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%.

Eligibility Criteria

Inclusion

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 removalby 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 (P2Y12receptor antagonists),
  • Patients without anticoagulation or anti-aggregating with indication of duodenal EMRor ESD (if duodenal cold snare EMR: only under anticoagulant or P2Y12 receptorantagonist),
  • Resection field of ESD or EMR is ≥ 20mm (same size restriction in case of endoscopicpapillectomy).

Exclusion

Exclusion Criteria:

  • Resection bed <20mm,
  • Subject currently enrolled in another interventional confounding research (nocontra-indication for image or blood collection in another protocol),
  • Incapacitated subjects, pregnant or lactating women.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: NEXPOWDER-ENDOHS
Phase:
Study Start date:
October 15, 2023
Estimated Completion Date:
July 30, 2024

Study 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).

Connect with a study center

  • AZ Maria Middelares

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • UZ Gasthuisberg (KUL)

    Leuven, Vlaams Brabant 3000
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge-Oostende

    Brugge, West-Vlaanderen 8000
    Belgium

    Active - Recruiting

  • AZ Delta Campus Rumbeke

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • CHU Saint-Pierre

    Brussel, 1000
    Belgium

    Active - Recruiting

  • Cliniques universitaires Saint-Luc (UCL)

    Brussels, 1200
    Belgium

    Active - Recruiting

  • HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)

    Brussels, 1070
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Groupe Santé CHC - Clinique du MontLégia

    Liège, 4000
    Belgium

    Active - Recruiting

  • Amsterdam UMC - Location AMC

    Amsterdam, 1105
    Netherlands

    Site Not Available

  • Amsterdam UMC - Location VUMC

    Amsterdam, 1081
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht, 3584
    Netherlands

    Site Not Available

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