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Phase IV Bioseal Study in Brain Tumor Surgery

NCT02034799 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2018-02-26

Study results available
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Summary

The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.

Conditions

  • Hemostasis
  • Meningioma Surgery

Interventions

BIOLOGICAL

Bioseal Fibrin Sealant

OTHER

Standard of Care (SoC)

Sponsors & Collaborators

  • Guangzhou Bioseal Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Kocharian, MD, PhD · Ethicon, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-01
Primary Completion
2014-08-01
Completion
2014-09-01

Countries

  • China

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 NCT02034799 on ClinicalTrials.gov