A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01719172
First received: October 30, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.


Condition Intervention
Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
Device: Veriset™ Hemostatic Patch

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment [ Time Frame: Intra-operative (Day 0) ] [ Designated as safety issue: No ]
    Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.


Secondary Outcome Measures:
  • Proportion of Subjects Who Achieve Hemostasis Within 1 Minute [ Time Frame: Intra-operative (Day 0) ] [ Designated as safety issue: No ]
    Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.

  • Median Time to Achieve Hemostasis [ Time Frame: Intra-operative (Day 0) ] [ Designated as safety issue: No ]
    Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.


Enrollment: 30
Study Start Date: September 2012
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veriset™ Hemostatic Patch
Topical hemostat
Device: Veriset™ Hemostatic Patch
Topical Hemostat

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject or authorized representative has provided informed consent.
  • Subject is ≥ 18 years old.
  • Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
  • Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
  • Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
  • TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).

Exclusion Criteria:

  • Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
  • Subject has an estimated life expectancy of less than 6 months.
  • Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
  • Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
  • Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study.
  • Subject has an active local infection at the TBS.
  • The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719172

Locations
Austria
Innsbruck, Austria
Germany
Hannover, Germany
München, Germany
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01719172     History of Changes
Other Study ID Numbers: COVEUST0278
Study First Received: October 30, 2012
Results First Received: January 17, 2014
Last Updated: January 17, 2014
Health Authority: Austria: Ethikkommission
Germany: Ethics Commission

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014