The EVARREST Pediatric Mild or Moderate Liver and Soft Tissue Bleeding US Study

  • participants needed
  • sponsor
    Ethicon, Inc.
Updated on 18 January 2021
Richard Kocharian, M.D., Ph.D.
Primary Contact
Children's National Medical Center (5.4 mi away) Contact
+8 other location


The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.


This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.

Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery.

Enrollment will be staggered by age. The first group will include 31 subjects 1 years to <18 years of age and the subsequent group will include 4 subjects from 1 month ( 28 days from birth) to <1 years of age. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrollment.

At least thirty-five (35) qualified pediatric subjects with an appropriate mild or moderate bleeding TBS will be enrolled in this study.

Treatment EVARREST® Fibrin Sealant Patch
Clinical Study IdentifierNCT03255174
SponsorEthicon, Inc.
Last Modified on18 January 2021

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer


user name

Annotated by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet