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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: Veriset™ Hemostatic Patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Veriset™ Hemostatic Patch<br>Topical hemostat | Device: Veriset™ Hemostatic Patch<br>* Topical Hemostat<br>|

What is the study measuring?
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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) |