Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection
NCT ID: NCT06096948
Last Updated: 2023-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-10-15
2024-07-30
Brief Summary
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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%.
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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NEXPOWDER-ENDOHS
Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.
NEXPOWDER-ENDOHS
Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.
Interventions
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NEXPOWDER-ENDOHS
Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Lemmers Arnaud
Professor Endoscopy Unit, Director of Clinic Department of Gastroenterology, Hepatopancreatology and Digestive Oncology Erasme Hospital,
Locations
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AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Gasthuisberg (KUL)
Leuven, Vlaams Brabant, Belgium
AZ Sint-Jan Brugge-Oostende
Bruges, West-Vlaanderen, Belgium
AZ Delta Campus Rumbeke
Roeselare, West-Vlaanderen, Belgium
CHU Saint-Pierre
Brussels, , Belgium
HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)
Brussels, , Belgium
Cliniques universitaires Saint-Luc (UCL)
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Groupe Santé CHC - Clinique du MontLégia
Liège, , Belgium
Amsterdam UMC - Location VUMC
Amsterdam, , Netherlands
Amsterdam UMC - Location AMC
Amsterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P2023/250
Identifier Type: OTHER
Identifier Source: secondary_id
B4062023000141
Identifier Type: OTHER
Identifier Source: secondary_id
NEXPOWDER-ENDOHS
Identifier Type: -
Identifier Source: org_study_id
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