Purastat Prevention Delayed Bleeding Duodenum

Last updated: November 9, 2020
Sponsor: Prof. Dr. Raf Bisschops
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT04629768
S63851
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 59
Study Start date:
October 02, 2020
Estimated Completion Date:
September 30, 2023

Connect with a study center

  • University Hospitals Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

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