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ClinicalTrials.gov ID

NCT06096948

Lead Sponsor

Erasme University HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

50Estimated

Last Update Posted

Oct 24, 2023Actual

Start Date

Oct 15, 2023Actual

Primary Completion Date

Apr 30, 2024Estimated

Completion Date

Jul 30, 2024Estimated

Official Title

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

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%.

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).

• Gastro Intestinal Bleeding
• Polyps

• NEXPOWDER-ENDOHS

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Prevention

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Erasme University HospitalOTHER

David.tate@uzgent.be+3293322300