NCT05746884

Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind. The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy. This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.

Conditions

• Duodenal Bleeding

Interventions

Type	Name	Description
PROCEDURE	duodenal mucosectomy	Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.
PROCEDURE	ampullectomy	Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.

Timeline

• Start date: 2023-08-21
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2023-02-28
• Last updated: 2026-02-27

Locations

1 site across 1 country: France