Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection

Polyps Clinical Trial

— NEX-ENDOHS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096948
• Other study ID #: NEXPOWDER-ENDOHS
• Secondary ID: P2023/250B406202
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: October 2023
• Source: Erasme University Hospital
• Contact: Arnaud Lemmers
• Phone: +3225556559
• Email: arnaud.lemmers[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Interventional

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%.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastro Intestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Polyps

Intervention

Device:
• NEXPOWDER-ENDOHS
Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge-Oostende	Brugge	West-Vlaanderen
Belgium	CHU Saint-Pierre	Brussel
Belgium	Cliniques universitaires Saint-Luc (UCL)	Brussels
Belgium	HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)	Brussels
Belgium	AZ Maria Middelares	Gent	Oost-Vlaanderen
Belgium	UZ Gent	Gent
Belgium	UZ Gasthuisberg (KUL)	Leuven	Vlaams Brabant
Belgium	Groupe Santé CHC - Clinique du MontLégia	Liège
Belgium	AZ Delta Campus Rumbeke	Roeselare	West-Vlaanderen
Netherlands	Amsterdam UMC - Location AMC	Amsterdam
Netherlands	Amsterdam UMC - Location VUMC	Amsterdam
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety in terms of Adverse Events (AE related to Nexpowder)	number of intraprocedural complications (perforation,…); number of post-procedure complications (delayed perforation, peritonitis,..)	1 month
Primary	Efficacy of Nexpowder in changing the delayed bleeding rate	Decrease the delayed bleeding rate	1 month