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

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.

Study Overview

• Status: Completed
• Conditions: Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
• Intervention / Treatment: Device: Veriset™ Hemostatic Patch

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
• Germany
  • Hannover, Germany
  • München, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veriset™ Hemostatic Patch; Topical hemostat	Device: Veriset™ Hemostatic Patch; Topical Hemostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intra-operative (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intra-operative (Day 0)
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.	Intra-operative (Day 0)

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: January 17, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: COVEUST0278