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Purastat Prevention Delayed Bleeding Duodenum

NCT ID: NCT04629768

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lesion; Duodenum

Keywords

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Purastat EMR duodenum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Duodenal EMR + PuraStat

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

Group Type OTHER

PuraStat

Intervention Type DEVICE

Purastat is applied to the EMR defect

Interventions

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PuraStat

Purastat is applied to the EMR defect

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3-D Matrix Europe SAS

INDUSTRY

Sponsor Role collaborator

Prof. Dr. Raf Bisschops

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Raf Bisschops

Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ingrid Demedts

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Raf Bisschops

Role: CONTACT

Phone: +3216342161

Email: [email protected]

Ingrid Demedts

Role: CONTACT

Phone: +3216345518

Email: [email protected]

Facility Contacts

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Raf Bisschops, MD PhD

Role: primary

Ingrid Demedts, MD PhD

Role: backup

Other Identifiers

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S63851

Identifier Type: -

Identifier Source: org_study_id