Back to resultsA Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
Primary Purpose
Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Veriset™ Hemostatic Patch
Sponsored by
About this trial
This is an interventional treatment trial for Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Veriset™ Hemostatic Patch
Arm Description
Topical hemostat
Outcomes
Primary Outcome Measures
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01719172
Brief Title
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
Official Title
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Veriset™ Hemostatic Patch
Arm Type
Experimental
Arm Description
Topical hemostat
Intervention Type
Device
Intervention Name(s)
Veriset™ Hemostatic Patch
Intervention Description
Topical Hemostat
Primary Outcome Measure Information:
Title
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
Description
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.
Time Frame
Intra-operative (Day 0)
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Achieve Hemostasis Within 1 Minute
Description
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.
Time Frame
Intra-operative (Day 0)
Title
Median Time to Achieve Hemostasis
Description
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.
Time Frame
Intra-operative (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Innsbruck
Country
Austria
City
Hannover
Country
Germany
City
München
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
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