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ArterX Safety and Efficacy Study for Cardiac Indications

NCT ID: NCT01957904

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.

Detailed Description

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Conditions

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Vascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ArterX Surgical Sealant

Group Type OTHER

ArterX Surgical Sealant

Intervention Type DEVICE

Interventions

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ArterX Surgical Sealant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\>18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study.

The subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee.

The subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol.

The subject is determined by the surgeon to be at risk for poor hemostasis.

Exclusion Criteria

Subject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up.

Subject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days.

Subject is pregnant, may become pregnant or is currently breast feeding

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tenaxis Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Krankenhaus Der Barmherzigen Bruder

Trier, , Germany

Site Status

Countries

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Germany

References

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Skorpil J, Paraforos A, Mandak J, Cohn WE, Hajek T, Friedrich I. Effective and rapid sealing of coronary, aortic and atrial suture lines dagger. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):720-4; discussion 724. doi: 10.1093/icvts/ivv061. Epub 2015 Mar 24.

Reference Type RESULT
PMID: 25810290 (View on PubMed)

Other Identifiers

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CLN-015

Identifier Type: -

Identifier Source: org_study_id