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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014