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

NCT01719172 | Completed Results DMC

• 1 other identifier: COVEUST0278
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

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.

Conditions

Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of Subjects Who Achieve Hemostasis Within 1 Minute

  Intra-operative (Day 0)

• Median Time to Achieve Hemostasis

  Intra-operative (Day 0)

Study Arms (1)

Veriset™ Hemostatic Patch

EXPERIMENTAL

Topical hemostat

Device: Veriset™ Hemostatic Patch

Interventions

Veriset™ Hemostatic Patch DEVICE

Topical Hemostat

Veriset™ Hemostatic Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

München, Germany

Location

Results Point of Contact

• Title: Julie Totten
• Organization: Covidien

Julie.Totten@Covidien.com

781-839-1729

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 27, 2014
• Results First Posted: February 27, 2014

Record last verified: 2014-01

Locations

DE (2); AU (1)