Skip to main content
OpenTrials
Completed

NCT Number: NCT02034799

Phase IV Bioseal Study in Brain Tumor Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemostasis Meningioma Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Investigation Site #6, Zhengzhou, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects between 18 and 75 years of age
  • Undergoing elective meningioma surgery and having a tumor cavity
  • Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis
  • Able and willing to comply with procedures required by protocol
  • Signed and dated written informed consent prior to any study related procedures.

Exclusion criteria

  • Subjects undergoing emergency surgery
  • Subjects with any intra-operative findings that may preclude conducting of the study procedures
  • Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the Target Bleeding Site (TBS)
  • Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products
  • Subjects who have a history of traumatic head injury
  • Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period
  • The subject, in the opinion of the investigator, would not be suitable for participation in the study
  • Subjects who participated in another trial within 30 days prior to the planned start of treatment.

Treatment and study plan

Bioseal Fibrin Sealant

Biological

Standard of Care (SOC)

Other

Primary outcomes

  1. Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.

    Time frame: Intra-operative, 6 minutes following randomization

    The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.

Secondary outcomes

  1. Hemostasis at the TBS at 3 Minutes Following Treatment Application

    Time frame: Intra-operative, 3 minutes following randomization

    The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS.

  2. Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.

    Time frame: Through 30-day follow-up

  3. Incidence of Potential Bleeding-related Adverse Events

    Time frame: Through 30-day follow-up

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Collaborators

  • Guangzhou Bioseal Biotechnology Co., Ltd.

Registry information

Official study title

A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2014
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.