Actively Recruiting
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2026-02-27
234
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
Sponsors
G
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.
CONDITIONS
Official Title
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Single ampullary lesion 10mm or larger
- Up to 2 duodenal lesions
- Lesion size 15mm or less
- Resection by hot ampullectomy or hot endoscopic mucosal resection
- Lesion morphology 0-Is, 0-IIa/b/c or combination, or submucosal lesions
You will not qualify if you...
- Unable to provide informed consent (including cognitive impairment)
- Pregnant or breastfeeding women
- Allergy to PuraStat®
- Cold mucosal endoscopic resection
- Under guardianship, curatorship, or deprived of liberty
- Currently participating or recently excluded from another clinical trial
- Not covered by a social security scheme
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Privé Jean Mermoz
Lyon, France
Actively Recruiting
Research Team
S
Sarah LEBLANC, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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