The Evicel Post-Authorization Surveillance Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

NCT04841330

Peripheral Intavenous Catheter Stabilization

COMPLETED

Clinical Study to Evaluate the Safety and Efficacy of the Vela100

NCT01026441

Cellulite Reduction Circumference Reduction

TERMINATED PHASE4

OsciPulse Device for the Prevention of VTE

NCT04625673

Venous Thromboembolism Deep Vein Thrombosis Pulmonary Thromboembolisms

COMPLETED NA

US Post-Market Surveillance Study of the Surfacer System

NCT05050799

Venous Disease

RECRUITING

Evaluation of the Safety and Efficacy of the DeScribe™ Patch

NCT02297321

Tattoos

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vascular Disease Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vascular Surgery Subjects Treated with EVICEL

EVICEL ™ Fibrin Sealant (Human)

Intervention Type BIOLOGICAL

Commercial Evicel

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EVICEL ™ Fibrin Sealant (Human)

Commercial Evicel

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fibrin Sealant (Human)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No