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

Medtronic

Status

Completed

Conditions

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

Treatments

Device: Veriset™ Hemostatic Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT01719172

COVEUST0278

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.