A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
This study is currently recruiting participants.
Verified August 2012 by Covidien
Sponsor:
Covidien
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01719172
First received: October 30, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach |
Device: Veriset™ Hemostatic Patch |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue |
Further study details as provided by Covidien:
Primary Outcome Measures:
- Percent success in obtaining hemostasis following Veriset Hemostatic Patch treatment. Success will be defined as hemostasis obtained within 5 minutes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Veriset™ Hemostatic Patch
Topical hemostat
|
Device: Veriset™ Hemostatic Patch
Topical Hemostat
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719172
Contacts
| Contact: Michael Rohan | 781- 839-1700 | Michael.Rohan@Covidien.com |
Locations
| Germany | |
| Technischen Universität München | Recruiting |
| München, Germany | |
| Contact: Beate Schossow 0049 89 4140-6469 | |
| Principal Investigator: Christoph Schuhmacher | |
Sponsors and Collaborators
Covidien
More Information
No publications provided
| Responsible Party: | Covidien |
| ClinicalTrials.gov Identifier: | NCT01719172 History of Changes |
| Other Study ID Numbers: | COVEUST0278 |
| Study First Received: | October 30, 2012 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Austria: Ethikkommission Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013