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OpenTrials
Completed

NCT Number: NCT02094885

The Bioseal Vascular Study

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Investigation Site #21, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects between 18 and 75 years of age;
  • 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 ;
  • 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 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 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 with known allergies to or previously used porcine derived products;
  • 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.

Treatment and study plan

Bioseal Fibrin Sealant

Biological

Manual compression

Other

Primary outcomes

  1. Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.

    Time frame: 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 outcomes

  1. Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application

    Time frame: 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.

  2. Number of Participants Requiring Alternative Treatment Due to Treatment Failure*

    Time frame: 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.

  3. Percentage of Participants With Potential Bleeding-related Adverse Events

    Time frame: 30-days follow-up

    Percentage of participants with potential bleeding-related adverse events by study group

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Collaborators

  • Guangzhou Bioseal Biotechnology Co., Ltd.

Registry information

Official study title

A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Manual Compression as an Adjunct to Hemostasis in the Patients Undergoing Elective Vascular Surgery

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2014
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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