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Purastat Prevention Delayed Bleeding Duodenum

Primary Purpose

Lesion; Duodenum

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PuraStat
Sponsored by
Prof. Dr. Raf Bisschops
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lesion; Duodenum focused on measuring Purastat, EMR duodenum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Duodenal EMR + PuraStat

Arm Description

PuraStat will be applied to the defect after duodenal EMR of the lesion

Outcomes

Primary Outcome Measures

The presence of active bleeding or high risk stigma of bleeding
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

Secondary Outcome Measures

The presence of clinical signs of delayed bleeding
The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application.
The presence of other adverse events
The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application
The feasibility of PuraStat application: Amount
The amount of PuraStat will be investigated: Volume in mL
The feasibility of PuraStat application: Ease
The ease of application will be investigated: Questionnaire will be answered by the endoscopist.
The feasibility of Purastat application: Coverage
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

Full Information

First Posted
August 31, 2020
Last Updated
November 9, 2020
Sponsor
Prof. Dr. Raf Bisschops
Collaborators
3-D Matrix Europe SAS
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1. Study Identification

Unique Protocol Identification Number
NCT04629768
Brief Title
Purastat Prevention Delayed Bleeding Duodenum
Official Title
A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Raf Bisschops
Collaborators
3-D Matrix Europe SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lesion; Duodenum
Keywords
Purastat, EMR duodenum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duodenal EMR + PuraStat
Arm Type
Other
Arm Description
PuraStat will be applied to the defect after duodenal EMR of the lesion
Intervention Type
Device
Intervention Name(s)
PuraStat
Intervention Description
Purastat is applied to the EMR defect
Primary Outcome Measure Information:
Title
The presence of active bleeding or high risk stigma of bleeding
Description
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
Time Frame
1 day after EMR
Secondary Outcome Measure Information:
Title
The presence of clinical signs of delayed bleeding
Description
The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application.
Time Frame
'During hospital stay, assessed up to 10 days' and '30 days after EMR'
Title
The presence of other adverse events
Description
The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application
Time Frame
'During hospital stay, assessed up to 10 days' and '30 days after EMR'
Title
The feasibility of PuraStat application: Amount
Description
The amount of PuraStat will be investigated: Volume in mL
Time Frame
During EMR procedure
Title
The feasibility of PuraStat application: Ease
Description
The ease of application will be investigated: Questionnaire will be answered by the endoscopist.
Time Frame
During EMR procedure
Title
The feasibility of Purastat application: Coverage
Description
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
Time Frame
During EGD procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raf Bisschops
Phone
+3216342161
Email
raf.bisschops@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Demedts
Phone
+3216345518
Email
ingrid.demedts@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Demedts
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raf Bisschops, MD PhD
Phone
+3216342161
Email
raf.bisschops@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Ingrid Demedts, MD PhD
Phone
+3216345518
Email
ingrid.demedts@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Raf Bisschops, MD PhD
First Name & Middle Initial & Last Name & Degree
Ingrid Demedts, MD PhD

12. IPD Sharing Statement

Learn more about this trial

Purastat Prevention Delayed Bleeding Duodenum

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