Phase 4
N=256
Phase IV Bioseal Study in Brain Tumor Surgery
Hemostasis · Meningioma Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02034799 ↗Enrolled (actual)
256
Serious AEs
5.9%
Results posted
Feb 2018
Primary outcome: Primary: Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. — 99.2; 100 % of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bioseal Fibrin Sealant (Biological); Standard of Care (SoC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon, Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. |
99.2; 100 | — |
| SECONDARY Hemostasis at the TBS at 3 Minutes Following Treatment Application |
89.9; 94.5 | — |
| SECONDARY Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. |
14; 14; 5; 3; 6; 8 | — |
| SECONDARY Incidence of Potential Bleeding-related Adverse Events |
18; 18 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02034799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.