Purastat Prevention Delayed Bleeding Duodenum
A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedStudy Start
First participant enrolled
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedNovember 16, 2020
November 1, 2020
2 years
August 31, 2020
November 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 day after EMR
Secondary Outcomes (5)
The presence of clinical signs of delayed bleeding
'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The presence of other adverse events
'During hospital stay, assessed up to 10 days' and '30 days after EMR'
The feasibility of PuraStat application: Amount
During EMR procedure
The feasibility of PuraStat application: Ease
During EMR procedure
The feasibility of Purastat application: Coverage
During EGD procedure
Study Arms (1)
Duodenal EMR + PuraStat
OTHERPuraStat will be applied to the defect after duodenal EMR of the lesion
Interventions
Eligibility Criteria
You may qualify if:
- Duodenal non-ampullary mucosal lesion ≥ 10 mm
- ≥ 18y of age
- Informed consent obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prof. Dr. Raf Bisschopslead
- 3-D Matrix Europe SAScollaborator
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Ingrid Demedts
UZ Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
August 31, 2020
First Posted
November 16, 2020
Study Start
October 2, 2020
Primary Completion
October 1, 2022
Study Completion
September 1, 2023
Last Updated
November 16, 2020
Record last verified: 2020-11