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Phase IV Bioseal Study in Brain Tumor Surgery

Primary Purpose

Hemostasis, Meningioma Surgery

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bioseal Fibrin Sealant
Standard of Care (SoC)
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemostasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Investigation Site #6
  • Clinical Investigation Site #5
  • Clinical Investigation Site #3
  • Clinical Investigation Site #4
  • Clinical Investigation Site #7
  • Clinical Investigation Site #2
  • Clinical Investigation Site #1

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard of Care (SoC)

Bioseal Fibrin Sealant

Arm Description

Standard of Care (SoC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Outcomes

Primary Outcome Measures

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

Hemostasis at the TBS at 3 Minutes Following Treatment Application
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.
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
Incidence of Potential Bleeding-related Adverse Events

Full Information

First Posted
January 10, 2014
Last Updated
August 17, 2017
Sponsor
Ethicon, Inc.
Collaborators
Guangzhou Bioseal Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02034799
Brief Title
Phase IV Bioseal Study in Brain Tumor Surgery
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2013 (Actual)
Primary Completion Date
August 1, 2014 (Actual)
Study Completion Date
September 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
Collaborators
Guangzhou Bioseal Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemostasis, Meningioma Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SoC)
Arm Type
Other
Arm Description
Standard of Care (SoC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Arm Title
Bioseal Fibrin Sealant
Arm Type
Experimental
Arm Description
A porcine-derived fibrin sealant consisting of thrombin and fibrinogen
Intervention Type
Biological
Intervention Name(s)
Bioseal Fibrin Sealant
Intervention Type
Other
Intervention Name(s)
Standard of Care (SoC)
Primary Outcome Measure Information:
Title
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.
Description
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.
Time Frame
Intra-operative, 6 minutes following randomization
Secondary Outcome Measure Information:
Title
Hemostasis at the TBS at 3 Minutes Following Treatment Application
Description
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.
Time Frame
Intra-operative, 3 minutes following randomization
Title
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
Time Frame
Through 30-day follow-up
Title
Incidence of Potential Bleeding-related Adverse Events
Time Frame
Through 30-day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kocharian, MD, PhD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigation Site #6
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Clinical Investigation Site #5
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Clinical Investigation Site #3
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Clinical Investigation Site #4
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Clinical Investigation Site #7
City
Beijing
ZIP/Postal Code
100048
Country
China
Facility Name
Clinical Investigation Site #2
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Clinical Investigation Site #1
City
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Phase IV Bioseal Study in Brain Tumor Surgery

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