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NCT03255174 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Controlling Mild to Moderate Bleeding During Surgery, sponsored by Ethicon.

Completed
Registry status
Phase 3
Development phase
35
Enrollment target
5
Study locations

NCT03255174 is a Phase 3 study of Controlling Mild to Moderate Bleeding During Surgery that has completed, run by Ethicon. The registered enrollment target is 35 participants. The trial reports 5 study locations across 3 states.

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The verdict

NCT03255174, a Phase 3 study of Controlling Mild to Moderate Bleeding During Surgery, has completed, sponsored by Ethicon.

COMPLETED
Registry status
Phase 3
Development phase
35 participants
Enrollment target
5
Study locations

Study Summary

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.

Interventions

  • BIOLOGICAL EVARREST® Fibrin Sealant Patch

Study Locations (5)

Other

  • Birmingham Chrildren's Hospital - Birmingham
  • Newcastle upon Tyne Hospitals NHS Foundation Trust - Newcastle upon Tyne
  • Southampton University Hospital - Southampton

Alabama

  • University of Alabama Hospital - Birmingham

New York

  • icahn School of Medicine at Mt Sinai - New York

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2018-03-20
Est. Completion 2025-02-14
Phase Phase 3

Sponsor

Ethicon

38 total trials

What the Registry Record Tells You About NCT03255174

The ClinicalTrials.gov registry entry for NCT03255174 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ethicon, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Controlling Mild to Moderate Bleeding During Surgery appearing as the primary indexed condition, and to 1 intervention - of which EVARREST® Fibrin Sealant Patch is the first listed.

NCT03255174 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Other, Alabama, New York.

Frequently Asked Questions

What is clinical trial NCT03255174 about?

NCT03255174 is a clinical study titled "The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study". 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 popula...

What is the current status of trial NCT03255174?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2018-03-20. Estimated completion is 2025-02-14.

What conditions does trial NCT03255174 study?

This clinical trial studies the following conditions: Controlling Mild to Moderate Bleeding During Surgery.

What interventions are being tested in trial NCT03255174?

The interventions under investigation include: EVARREST® Fibrin Sealant Patch (BIOLOGICAL).

Who is sponsoring clinical trial NCT03255174?

This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03255174 being conducted?

This trial has 5 study locations across Alabama, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.