HemostasisPhase 4NCT02034799
Phase IV Bioseal Study in Brain Tumor Surgery
A Phase 4 study testing Bioseal Fibrin Sealant in people with Hemostasis and Meningioma Surgery, run by Ethicon, Inc. at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemostasis, Meningioma Surgery
- What is being tested?
- Bioseal Fibrin Sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 7 sitesChina
- Study dates
- 1 Nov 2013to 1 Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Clinical Investigation Site #7
Beijing, 100048
Clinical Investigation Site #5
Changsha, Hunan, 410008
Clinical Investigation Site #3
Chengdu, Sichuan, 610041
Clinical Investigation Site #4
Hangzhou, Zhejiang, 310009
Clinical Investigation Site #2
Shanghai, 200040
Clinical Investigation Site #1
Tianjin, 300052
Clinical Investigation Site #6
Zhengzhou, Henan, 450052
About this study
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
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
- Being tested
- Bioseal Fibrin Sealant, Standard of Care (SoC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioseal Fibrin SealantBiological
Standard of Care (SoC)Other
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of Care (SoC) |
| Bioseal Fibrin Sealant | Experimental | A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Receives: Biological: Bioseal Fibrin Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operative, 6 minutes following randomization
Secondary outcomes (3)
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.
Measured: Intra-operative, 3 minutes following randomization
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
Measured: Through 30-day follow-up
Incidence of Potential Bleeding-related Adverse Events
Measured: Through 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study start1 Nov 2013
- Primary completion1 Aug 2014
- Study completion1 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Bioseal Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Richard Kocharian, MD, PhD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034799
- Sponsor's protocol ID
- BIOS-13-002
- Status last verified
- Aug 2017
- First submitted
- 10 Jan 2014
- Last updated
- 26 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02034799
- Acronym / sponsor ID
- BIOS-13-002
- Conditions
- Hemostasis, Meningioma Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Bioseal Biotechnology Co., Ltd.
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 1 Sep 2014 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Posted 26 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | Other | Other: Standard of Care (SoC)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. |
| Bioseal Fibrin Sealant | Experimental | Biological: Bioseal Fibrin SealantA porcine-derived fibrin sealant consisting of thrombin and fibrinogen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioseal Fibrin Sealant | Biological | Bioseal Fibrin Sealant |
| Standard of Care (SoC) | Other | Standard of Care (SoC) |
Primary outcome
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.
3 secondary outcomes
Hemostasis at the TBS at 3 Minutes Following Treatment Application
Time frame: Intra-operative, 3 minutes following randomization
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
Time frame: Through 30-day follow-up
Incidence of Potential Bleeding-related Adverse Events
Time frame: Through 30-day follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Kocharian, MD, PhD study director
Ethicon, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bioseal Fibrin Sealant in people with Hemostasis and Meningioma Surgery, run by Ethicon, Inc. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.