Polyps Clinical Trial
— NEX-ENDOHSOfficial title:
Safety and Efficacy of a New Hemostatic System to Prevent Delayed Bleeding After Endoscopic Resection in a Selected High-risk Population
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%.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium, Netherlands,
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 |
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