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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01158261
Other study ID # 400-08-004
Secondary ID
Status Completed
Phase N/A
First received July 6, 2010
Last updated July 22, 2015
Start date June 2010
Est. completion date May 2014

Study information

Verified date July 2015
Source Ethicon, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date May 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery

- EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es

- Subjects must be willing to and capable of participating in the study, and provide written informed consent

Exclusion Criteria:

- Subjects with known intolerance to blood products

- Subjects unwilling to receive blood products

- Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding

- Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Biological:
EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel

Locations

Country Name City State
United States Baptist Health Medical Center Jacksonville Florida
United States Memorial Hospital Jacksonville Florida

Sponsors (2)

Lead Sponsor Collaborator
Ethicon, Inc. OMRIX Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Specific Safety Parameters Incidence of graft occlusion
Incidence of adverse events potentially related to non-graft thrombotic events
Incidence of bleeding events
Up to 4-weeks post-operatively Yes
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