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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Postmarket Surveillance Study


 
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General
Study Status Study Pending
522 Number / Requirement Number PS200004 / PSS001
Date Current Plan Accepted  
Study Name Postmarket Surveillance Study
Root Document Number DEN190038 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description On label, single arm, observational, multi- center, consecutively enrolling, post-market

surveillance study.

Study Population Description Patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the

device labeling.

Inclusion Criteria

1. Subjects have been referred for placement of central venous access, i.e. placement of catheter, nutritional line, etc.

2. Subjects with upper body venous

occlusions or other conditions thatpreclude central venous access by conventional methods

3. Subjects are willing and able to give written informed consent

Exclusion Criteria:



• Subjects will be contraindicated if one of the following are found

o Occlusion of the right femoral vein;

o Occlusion of the iliac vein;

o Occlusion of the inferior vena cava.



• Subject with acute thrombosis within any vessel (Superior Vena Cava (SVC), jugular, inferior vena cava (IVC), brachiocephalic and subclavian) planned to be crossed by Surfacer System.

• Subjects with tortuous anatomy which precludes a straight line from femoral venous entry to subclavian exit.



Sample Size A minimum of 30 patients will be enrolled in the study, all cases will be performed at 10-12 sites.



Investigators will invite patients who will be treated with the device in accordance with the

approved labeling and who met enrollmentcriteria to join the study. All patients who sign a consent form will be assigned a PMS identification number. The identification number will be formatted using site identification number

– sequential site recruited patient number (i.e. 05-04). Any patient meeting the PMS inclusion criteria, for whom this device is indicated, can be recruited.



Data Collection The study physician or his designee at each clinical site will perform primary data collection. Only the study physician or other pre-designated study personnel will be authorized to enter data (from patient’s medical records, i.e.,

the source documents) via internet-based e- CRFs.



All study data will be collected on standardized electronic Case Report Forms (eCRFs).

Electronic CRFs must be signed electronically by the PI listed in the Clinical Trial Agreement and Delegation of Authority Log. If for any reason an eCRF is unavailable and/or inaccessible, a paper CRF will be provided by the trial Sponsor to be completed, signed by the Principal Investigator or designee and submitted to BVT.



Only anonymous data will be collected after the patient has consented that personal data can be used.

Follow-up Visits and Length of Follow-up Patients will be followed for 24 hours. Data willbe collected at the following timepoints



Baseline, procedure, discharge and 24 hours post procedure. Post procedural complication assessments are expected to occur within 24 hours.



Postmarket Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/23/2021   Overdue
1 year report 02/22/2022    
18 month report 08/23/2022    
2 year report 02/22/2023    


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