Back to resultsHaemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding (PURASTAT)
Primary Purpose
Duodenal Bleeding
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
duodenal mucosectomy
ampullectomy
Sponsored by
About this trial
This is an interventional treatment trial for Duodenal Bleeding
Eligibility Criteria
Inclusion Criteria: Ampullary lesions Single ampullary lesion ≥ 10mm Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions ≤ 2 lesions Lesion ≥15mm Resection via hot Endoscopic mucosal resection Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions Exclusion Criteria: Inability to provide informed consent (including people with cognitive impairment); Pregnant or breastfeeding women; Allergy to PuraStat®; "Cold" mucosal endoscopic resection; Patient under guardianship or curatorship, or under a regime of deprivation of liberty; Participating patient, or in a period of exclusion from another clinical trial; Patient not benefiting from a social security scheme.
Sites / Locations
- Hôpital Privé Jean MermozRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group with PuraStat®
Control Group
Arm Description
Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®
Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion
Outcomes
Primary Outcome Measures
Bleeding rate requiring further intervention within 30 days
Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)
Secondary Outcome Measures
Full Information
NCT ID
NCT05746884
First Posted
February 13, 2023
Last Updated
August 29, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05746884
Brief Title
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
Acronym
PURASTAT
Official Title
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.
Masking
Participant
Masking Description
single blind
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group with PuraStat®
Arm Type
Experimental
Arm Description
Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion
Intervention Type
Procedure
Intervention Name(s)
duodenal mucosectomy
Intervention Description
Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.
Intervention Type
Procedure
Intervention Name(s)
ampullectomy
Intervention Description
Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.
Primary Outcome Measure Information:
Title
Bleeding rate requiring further intervention within 30 days
Description
Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ampullary lesions
Single ampullary lesion ≥ 10mm
Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
≤ 2 lesions
Lesion ≥15mm
Resection via hot Endoscopic mucosal resection
Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions
Exclusion Criteria:
Inability to provide informed consent (including people with cognitive impairment);
Pregnant or breastfeeding women;
Allergy to PuraStat®;
"Cold" mucosal endoscopic resection;
Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
Participating patient, or in a period of exclusion from another clinical trial;
Patient not benefiting from a social security scheme.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah LEBLANC, MD
Phone
622222064
Ext
+33
Email
sarahleblanc34@hotmail.com
Facility Information:
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah LEBLANC, MD
Email
s.leblanc@gelmad.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
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