Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach Clinical Trial
Official title:
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
| Verified date | January 2014 |
| Source | Medtronic - MITG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: EthikkommissionGermany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | June 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic - MITG |
Austria, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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) | No |