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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Long Term Safety


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General
Study Status Progress Adequate
Application Number P010047 / PAS001
Date Current Protocol Accepted 03/16/2015
Study Name Long Term Safety
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, non-randomized, controlled observational study with a ProGel PALS group and a comparison group of standard-of-care, multi-center cohort study.

Study Population Description Newly enrolled consecutive patients post-approval study population
Sample Size 400 evaluable subjects (267 ProGEL Sealant + 133 Control) at up to 30 U.S. sites.

Data Collection Primary Endpoints:

The study will include evaluation of twelve safety endpoints (i.e. specified AE). These include:

1. Pneumothorax

2. Air leak, persistent

3. Air leak, late onset

4. Residual pleural space

5. Acute respiratory distress syndrome (ARDS)

6. Post-surgical renal abnormalities

7. Myocardial infarction

8. Atrial arrhythmia requiring treatment

9. Ventricular arrhythmia requiring treatment

10. Cardiac arrest (resuscitated)

11. Death (all causes)

12. Hospital readmission (related to pulmonary surgery)

Follow-up Visits and Length of Follow-up 5 years: 30-day and 90-day follow-up visits are scheduled for study assessments

Interim or Final Data Summary
Actual Number of Patients Enrolled 444 (400 subject as per protocol)
Actual Number of Sites Enrolled 22
Patient Follow-up Rate The follow-up rate at the end of the study was 392 divided by 444= 88%
Final Safety Findings Slightly lower rates were reported for persistent air leak in ProGel 14.5% vs. control 14.8%, [RR = 0.98 (95%CI: 0.62, 1.56) p = 0.937], and for atrial arrhythmia ProGel 16% vs. control 16% [RR = 0.99 (95%CI: 0.64, 1.55) p = 0.980]. Higher rate was reported for pneumothorax in ProGel 18.1% vs. control 10.5% [RR = 1.72 (95%CI: 1.03, 2.88) p = 0.033], and the association was statistically significant. ProGel group had 1.15 times more subjects with at least one specified adverse event. SAEs that occurred in greater than 3% in either group were hospital readmission 20 per 282 (7%) ProGel and 14 per 162 (9%) control, persistent air leak 23 per 282 (8%) ProGel and 15 per 162 (9%) control, pneumothorax ProGel 18 per 282 (6%) and control 8 per 162 (5%), atrial arrhythmia ProGel 2 per 282 (0.7%) and control 6 per 162 (4%), and death due to all causes 7 per 282 (3%) ProGel and 6 per 162 (4%) control. All other specified SAEs were reported in rates less than 1.5% in both groups. The rest of serious adverse event rates in the two study arms are pretty similar and lower or equal to the rate observed in the original PMA clinical report.
Final Effect Findings No effectiveness study endpoints were included in the approved protocol.
Study Strengths & Weaknesses Prospective cohort study design

Multi-center decreases potential selection bias and increases generalizability. The demographic distribution of patients reflects the population that requires this type of treatment.

Control group included

The follow-up rate of 88% is above the 80% that FDA recommends.

Study Weaknesses:

Non-randomized

44% of PAS treatment arm applications were off-label
Recommendations for Labeling Changes Labeling changes are recommended based on safety data reported in the final report.


Long Term Safety Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 01/14/2011 01/14/2011 On Time
18 month report 07/15/2011 07/14/2011 On Time
2 year report 01/14/2012 01/13/2012 On Time
rqst to change report dates 10/16/2012 10/16/2012 On Time
3 year report 01/13/2013 01/14/2013 Overdue/Received
4 year report 01/13/2014 01/13/2014 On Time
5 year report 01/13/2015 01/12/2015 On Time
6 year report 01/13/2016 01/12/2016 On Time
Final Report 04/01/2016 04/01/2016 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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