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Purastat Prevention Delayed Bleeding Duodenum

NCT04629768 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-11-16

No results posted yet for this 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.

Conditions

  • Lesion; Duodenum

Interventions

DEVICE

PuraStat

Purastat is applied to the EMR defect

Sponsors & Collaborators

  • 3-D Matrix Europe SAS

    collaborator INDUSTRY

  • Prof. Dr. Raf Bisschops

    lead OTHER

Principal Investigators

  • Ingrid Demedts · UZ Leuven

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2022-10-31
Completion
2023-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04629768 on ClinicalTrials.gov