The Bioseal Vascular Study

Phase 4

Completed

• Conditions: Vascular Bleeding; Cardiovascular Bleeding; Hemorrhage

• Registration Number: NCT02094885
• Lead Sponsor: Ethicon, Inc.

Brief Summary

To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Primary Completion: 2014-11-01
• Study Completion: 2014-12-01
• Results First Submitted: 2016-07-26
• Results First Submitted QC: 2016-07-26
• Results First Posted: 2016-09-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Subjects between 18 and 75 years of age;
2. Undergoing elective vascular surgical procedures and with the presence of an appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ;
3. Able and willing to comply with procedures required by protocol;
4. Signed and dated written informed consent prior to any study related procedures.

Exclusion Criteria

1. Subjects with any intra-operative findings that may preclude conducting of the study procedures;
2. Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS;
3. Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
4. Subjects with known allergies to or previously used porcine derived products;
5. Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period.
6. The subject, in the opinion of the investigator, would not be suitable for participation in the study.
7. Subjects who participated in another trial within 30 days prior to the planned start of treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.	Intra-operative, 10 minutes following randomization	Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Requiring Alternative Treatment Due to Treatment Failure*	Intra-operative, 10 minutes following randomization	Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.
Percentage of Participants With Potential Bleeding-related Adverse Events	30-days follow-up	Percentage of participants with potential bleeding-related adverse events by study group
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application	Intra-operative, 3 and 6 minutes following randomization	Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.

Trial Locations

Locations (9)

Clinical Investigation Site #21; 🇨🇳 Guangzhou City, Guangdong, China

Clinical Investigation Site #32; 🇨🇳 Nanjing, Jiangsu, China

Clinical Investigation Site #31; 🇨🇳 Nanjing, Jiangsu, China

Clinical Investigation Site #30; 🇨🇳 Jinan, Shandong, China

Clinical Investigation Site #22; 🇨🇳 Chengdu, Sichuan, China

Clinical Investigation Site #26; 🇨🇳 Beijing, China

Clinical Investigation Site #28; 🇨🇳 Beijing, China

Clinical Investigation Site #25; 🇨🇳 Shanghai, China

Clinical Investigation Site #23; 🇨🇳 Shanghai, China