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

NCT ID: NCT01719172

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Veriset™ Hemostatic Patch

Topical hemostat

Group Type: EXPERIMENTAL

Veriset™ Hemostatic Patch

Intervention Type: DEVICE

Topical Hemostat

Interventions

Veriset™ Hemostatic Patch

Topical Hemostat

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Innsbruck, , Austria

Hanover, , Germany

München, , Germany

Countries

Austria; Germany

Other Identifiers

COVEUST0278

Identifier Type: -

Identifier Source: org_study_id