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Purastat Prevention Delayed Bleeding Duodenum

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ClinicalTrials.gov Identifier: NCT04629768
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
3-D Matrix Europe SAS
Information provided by (Responsible Party):
Prof. Dr. Raf Bisschops, Universitaire Ziekenhuizen KU Leuven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lesion; Duodenum Device: PuraStat Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. The feasibility of PuraStat application: Amount [ Time Frame: During EMR procedure ]
    The amount of PuraStat will be investigated: Volume in mL

  4. 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.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629768


Contacts
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Contact: Raf Bisschops +3216342161 raf.bisschops@uzleuven.be
Contact: Ingrid Demedts +3216345518 ingrid.demedts@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Raf Bisschops, MD PhD    +3216342161    raf.bisschops@uzleuven.be   
Contact: Ingrid Demedts, MD PhD    +3216345518    ingrid.demedts@uzleuven.be   
Sub-Investigator: Raf Bisschops, MD PhD         
Principal Investigator: Ingrid Demedts, MD PhD         
Sponsors and Collaborators
Prof. Dr. Raf Bisschops
3-D Matrix Europe SAS
Investigators
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Principal Investigator: Ingrid Demedts UZ Leuven
More Information
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Responsible Party: Prof. Dr. Raf Bisschops, Clinical professor, Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT04629768    
Other Study ID Numbers: S63851
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Raf Bisschops, Universitaire Ziekenhuizen KU Leuven:
Purastat
EMR duodenum
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes