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

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.

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.