NEX-ENDOHS: Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection

Sponsor

Erasme University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06096948

Collaborator

(none)

Enrollment

Locations

Arm

9.5

Anticipated Duration (Months)

4.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Oct 15, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

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.

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

Primary Outcome Measures

Safety in terms of Adverse Events (AE related to Nexpowder) [1 month]
number of intraprocedural complications (perforation,…) number of post-procedure complications (delayed perforation, peritonitis,..)
Efficacy of Nexpowder in changing the delayed bleeding rate [1 month]
Decrease the delayed bleeding rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	AZ Maria Middelares	Gent	Oost-Vlaanderen	Belgium	9000
2	UZ Gasthuisberg (KUL)	Leuven	Vlaams Brabant	Belgium	3000
3	AZ Sint-Jan Brugge-Oostende	Brugge	West-Vlaanderen	Belgium	8000
4	AZ Delta Campus Rumbeke	Roeselare	West-Vlaanderen	Belgium	8800
5	HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)	Brussels		Belgium	1070
6	Cliniques universitaires Saint-Luc (UCL)	Brussels		Belgium	1200
7	CHU Saint-Pierre	Brussel		Belgium	1000
8	UZ Gent	Gent		Belgium	9000
9	Groupe Santé CHC - Clinique du MontLégia	Liège		Belgium	4000
10	Amsterdam UMC - Location VUMC	Amsterdam		Netherlands	1081
11	Amsterdam UMC - Location AMC	Amsterdam		Netherlands	1105
12	UMC Utrecht	Utrecht		Netherlands	3584

Sponsors and Collaborators

Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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
B4062023000141

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Oct 24, 2023