PURASTAT: Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05746884

Collaborator

(none)

234

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Duodenal Bleeding	Procedure: duodenal mucosectomy Procedure: ampullectomy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.

Masking:

Single (Participant)

Masking Description:

single blind

Primary Purpose:

Treatment

Official Title:

Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group with PuraStat® Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®	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.
Active Comparator: Control Group Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion	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.

Arm

Intervention/Treatment

Experimental: Experimental Group with PuraStat®

Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat®

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.

Active Comparator: Control Group

Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion

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.

Outcome Measures

Primary Outcome Measures

Bleeding rate requiring further intervention within 30 days [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GCS Ramsay Santé pour l'Enseignement et la Recherche

ClinicalTrials.gov Identifier:

NCT05746884

Other Study ID Numbers:

2022-A02660-43

First Posted:

Feb 28, 2023

Last Update Posted:

Feb 28, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemorrhage

Study Results

No Results Posted as of Feb 28, 2023