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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06096948
Recruitment Status : Recruiting
First Posted : October 24, 2023
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
Lemmers Arnaud, Erasme University Hospital

Study Description
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Brief 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%.


Condition or disease Intervention/treatment Phase
Gastro Intestinal Bleeding Polyps Device: NEXPOWDER-ENDOHS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of a New Hemostatic System to Prevent Delayed Bleeding After Endoscopic Resection in a Selected High-risk Population
Actual Study Start Date : October 15, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : July 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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,..)

  2. Efficacy of Nexpowder in changing the delayed bleeding rate [ Time Frame: 1 month ]
    Decrease the delayed bleeding rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06096948


Contacts
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Contact: Arnaud Lemmers +3225556559 arnaud.lemmers@hubruxelles.be
Contact: Julia Chaves Rodriguez +3225551779 julia.chaves.rodriguez@ulb.be

Locations
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Belgium
AZ Maria Middelares Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Pieter Dewint, MD, PhD    +3292467141    pieter.dewint@azmmsj.be   
Contact: Margaux Vansteelant    +3292467145    Margaux.Vansteelant@azmmsj.be   
UZ Gasthuisberg (KUL) Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Raf Bisschops, MD, PhD    +3216341946    raf.bisschops@uzleuven.be   
Contact: Chelsea Camps    +3216341946    chelsea.camps@uzleuven.be   
AZ Sint-Jan Brugge-Oostende Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
Contact: Christophe Snauwaert    +3250452180    christophe.snauwaert@azsintjan.be   
Contact: Nathalie Backers    +3250452180    nathalie.backers@azsintjan.be   
AZ Delta Campus Rumbeke Recruiting
Roeselare, West-Vlaanderen, Belgium, 8800
Contact: Dominiek De Wulf    +3251237172    Dominiek.DeWulf@azdelta.be   
Contact: Katleen Kerstens    +3251237172    katleen.kerstens@azdelta.be   
HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB) Recruiting
Brussels, Belgium, 1070
Contact: Arnaud Lemmers, MD,PhD    +3225556559    arnaud.lemmers@erasme.ulb.ac.be   
Contact: Julia Chaves Rodriguez, MD    +3225551779    Julia.Chaves.Rodriguez@ulb.be   
Principal Investigator: Arnaud Lemmers, MD,PhD         
Sub-Investigator: Jacques Devière, MD,PhD         
Sub-Investigator: Vincent Huberty, 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         
Cliniques universitaires Saint-Luc (UCL) Recruiting
Brussels, Belgium, 1200
Contact: Pierre Deprez, MD, PhD    +3227642849    pdeprez@saintluc.uclouvain.be   
CHU Saint-Pierre Recruiting
Brussel, Belgium, 1000
Contact: Pierre Eisendrath, MD, PhD    +3225354856    pierre.eisendrath@stpierre-bru.be   
Contact: Katty Renard    +3225354856    katty.renard@stpierre-bru.be   
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: David Tate, MD, PhD    +3293322300    David.tate@uzgent.be   
Contact: Karolien Haenebalcke    +3293322300    Karolien.Haenebalcke@uzgent.be   
Groupe Santé CHC - Clinique du MontLégia Recruiting
Liège, Belgium, 4000
Contact: Philippe Leclercq    +3243554211    philippe.leclercq@chc.be   
Contact: Alexandro Maniglia    +3243554211    alexandro.maniglia@chc.be   
Netherlands
Amsterdam UMC - Location VUMC Not yet recruiting
Amsterdam, Netherlands, 1081
Contact: Roos Pouw, MD       r.e.pouw@amsterdamumc.nl   
Sub-Investigator: Jacques Bergman, MD         
Amsterdam UMC - Location AMC Not yet recruiting
Amsterdam, Netherlands, 1105
Contact: Barbara Bastiaansen, MD       b.a.bastiaansen@amsterdamumc.nl   
Sub-Investigator: Evelien Dekker, MD         
UMC Utrecht Not yet recruiting
Utrecht, Netherlands, 3584
Contact: Leon Moons       L.M.G.Moons@umcutrecht.nl   
Contact: Bas Weusten       b.l.a.weusten@umcutrecht.nl   
Sponsors and Collaborators
Erasme University Hospital
More Information
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Responsible Party: Lemmers Arnaud, Professor Endoscopy Unit, Director of Clinic Department of Gastroenterology, Hepatopancreatology and Digestive Oncology Erasme Hospital,, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT06096948    
Other Study ID Numbers: NEXPOWDER-ENDOHS
P2023/250 ( Other Identifier: ERASME ETHICS COMMITTEE )
B4062023000141 ( Other Identifier: ERASME ETHICS COMMITTEE )
First Posted: October 24, 2023    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases