- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957904
ArterX Safety and Efficacy Study for Cardiac Indications
Prospective, Multi-Center, Open-Label, Post-Market ArterX® Safety and Efficacy Study Protocol for Cardiac Indications
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trier, Germany
- Krankenhaus der Barmherzigen Brüder
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ArterX Surgical Sealant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with immediate sealing of suture/staple line
Time Frame: during surgery
|
Immediate sealing of the suture/staple line at point of use upon release of the clamps, as evidenced by an absence of clinically significant bleeding as determined by physician investigator in procedures completed using the ArterX device.
|
during surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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