Status:
UNKNOWN
Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection
Lead Sponsor:
Erasme University Hospital
Conditions:
Gastro Intestinal Bleeding
Polyps
Eligibility:
All Genders
18+ years
Phase:
NA
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 indicatio...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06096948
Start Date
October 15 2023
End Date
July 30 2024
Last Update
October 24 2023
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium, 9000
2
UZ Gasthuisberg (KUL)
Leuven, Vlaams Brabant, Belgium, 3000
3
AZ Sint-Jan Brugge-Oostende
Bruges, West-Vlaanderen, Belgium, 8000
4
AZ Delta Campus Rumbeke
Roeselare, West-Vlaanderen, Belgium, 8800