Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Gastro Intestinal Bleeding, Polyps

Intervention / Treatment
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* Device: NEXPOWDER-ENDOHS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEXPOWDER-ENDOHS<br>Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding. | Device: NEXPOWDER-ENDOHS<br>* Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Efficacy of Nexpowder in changing the delayed bleeding rate | Decrease the delayed bleeding rate | 1 month |