Phase IV Bioseal Study in Brain Tumor Surgery

NCT02034799 | Completed Phase 4 Results

• 1 other identifier: BIOS-13-002
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 7

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.

Conditions

Hemostasis; Meningioma Surgery

Outcome Measures

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.

  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.

  Intra-operative, 6 minutes following randomization

Secondary Outcomes (3)

• Hemostasis at the TBS at 3 Minutes Following Treatment Application

  Intra-operative, 3 minutes following randomization

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

  Through 30-day follow-up

• Incidence of Potential Bleeding-related Adverse Events

  Through 30-day follow-up

Study Arms (2)

Standard of Care (SoC)

OTHER

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.

Other: Standard of Care (SoC)

Bioseal Fibrin Sealant

EXPERIMENTAL

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Biological: Bioseal Fibrin Sealant

Interventions

Bioseal Fibrin Sealant BIOLOGICAL

Bioseal Fibrin Sealant

Standard of Care (SoC) OTHER

Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead
• Guangzhou Bioseal Biotechnology Co., Ltd.: collaborator

Study Sites (7)

Clinical Investigation Site #6

Zhengzhou, Henan, 450052, China

Location

Clinical Investigation Site #5

Changsha, Hunan, 410008, China

Location

Clinical Investigation Site #3

Chengdu, Sichuan, 610041, China

Location

Clinical Investigation Site #4

Hangzhou, Zhejiang, 310009, China

Location

Clinical Investigation Site #7

Beijing, 100048, China

Location

Clinical Investigation Site #2

Shanghai, 200040, China

Location

Clinical Investigation Site #1

Tianjin, 300052, China

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Senior Director of Ethicon Clinical R&D
• Organization: Ethicon, Inc

jbatill2@its.jnj.com

(908) 218-2492

Study Officials

• Richard Kocharian, MD, PhD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 26, 2018
• Results First Posted: February 26, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (7)