N/A
N=30
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
Bottom Line
View on ClinicalTrials.gov: NCT01719172 ↗Enrolled (actual)
30
Serious AEs
36.7%
Results posted
Feb 2014
Primary outcome: Primary: Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment — 29 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Veriset™ Hemostatic Patch (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment |
29 | <0.0001 sig |
| SECONDARY Proportion of Subjects Who Achieve Hemostasis Within 1 Minute |
21 | 0.0214 sig |
| SECONDARY Median Time to Achieve Hemostasis |
1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01719172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.