Trials Sponsors Conditions Drugs Pricing

Conditions

Duodenal Bleeding

Outcome Measures

Primary Outcomes (1)

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)
30 days

Study Arms (2)

Experimental Group with PuraStat®

EXPERIMENTAL

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

Procedure: duodenal mucosectomyProcedure: ampullectomy

Control Group

ACTIVE COMPARATOR

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

Procedure: duodenal mucosectomyProcedure: ampullectomy

Interventions

duodenal mucosectomyProcedure

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

Control GroupExperimental Group with PuraStat®

ampullectomyProcedure

Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ampullary lesions
Single ampullary lesion ≥ 10mm

Sponsors & Collaborators

Euraxi Pharma
Industrycollaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche
Otherlead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, France

Enrollment

67 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: single blind
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 28, 2023

Study Start

August 21, 2023

Study Stopped

Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Experimental Group with PuraStat®

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Experimental Group with PuraStat®

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations