Purastat Prevention Delayed Bleeding Duodenum

Prof. Dr. Raf Bisschops

Status: Unknown

Conditions: Lesion; Duodenum

Treatments: Device: PuraStat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04629768

S63851

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Duodenal EMR + PuraStat

Other group

Description:

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

Treatment:

Device: PuraStat