Purastat Prevention Delayed Bleeding Duodenum

November 9, 2020 updated by: Prof. Dr. Raf Bisschops

A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions

PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Raf Bisschops, MD PhD
        • Principal Investigator:
          • Ingrid Demedts, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Duodenal non-ampullary mucosal lesion ≥ 10 mm
  • ≥ 18y of age
  • Informed consent obtained

Exclusion Criteria:

  • Ampulloma
  • Submucosal lesion
  • Lesion < 10 mm
  • >1 lesion resected
  • Active use of anticoagulant or antithrombotic medication other than aspirin
  • Known clotting disorder
  • Inability to give informed consent
  • < 18y of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Duodenal EMR + PuraStat
PuraStat will be applied to the defect after duodenal EMR of the lesion
Device: PuraStat
Purastat is applied to the EMR defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of active bleeding or high risk stigma of bleeding
Time Frame: 1 day after EMR
On an EGD, performed the day after the duodenal EMR with PuraStat application, the presence of active bleeding or the presence of visible vessels after removal of a blood clot will be observed
1 day after EMR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of clinical signs of delayed bleeding
Time Frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application.
'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The presence of other adverse events
Time Frame: 'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application
'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The feasibility of PuraStat application: Amount
Time Frame: During EMR procedure
The amount of PuraStat will be investigated: Volume in mL
During EMR procedure
The feasibility of PuraStat application: Ease
Time Frame: During EMR procedure
The ease of application will be investigated: Questionnaire will be answered by the endoscopist.
During EMR procedure
The feasibility of Purastat application: Coverage
Time Frame: During EGD procedure
Is PuraStat covering the resection defect the day after the EMR? This will be investigated by questionnaire that will be answered by the endoscopist who performs the EGD
During EGD procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Raf Bisschops

Collaborators

3-D Matrix Europe SAS

Investigators

  • Principal Investigator: Ingrid Demedts, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S63851

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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