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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Epi proColon PAS


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General
Study Status Progress Adequate
Application Number P130001 / PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-Epi proColon PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a single arm, prospective, multi-center, longitudinal,

new enrollment study designed to evaluate the performance of the Epi proColon test by the following measures: test accuracy, longitudinal adherence to Epi proColon screening, adherence

to follow-up colonoscopy, diagnostic yield, and assay failure.

These are to be assessed in a population of patients at average risk for colorectal cancer, who after appropriate counseling from their healthcare provider, have been offered and declined screening by fecal occult blood testing and colonoscopy.



The primary objectives are:

a) To demonstrate that the proportion of subjects with a positive test (EPC+) result at Time 1 (T1), but without colorectal cancer as assessed by colonoscopy (D-), i.e., PrT1 (D-, EPC +), is significantly less than the proportion of subjects at baseline/Time zero (T0) with a positive test result but without colorectal cancer, PrT0 (D-, EPC +).

b) To demonstrate the Epi proColon detects colorectal cancer at T1 in patients that tested negative at T0.

Study Population Description Adults of either sex, 50 years or older (but younger than 75), defined as average risk for CRC, who have been offered and have a history of not completing CRC screening.
Sample Size The sample size was determined based on a probability between 85 and 94% of being able to detect a colorectal cancer positive patient at T1 (assuming that patient tested negative at T0) using the Epi proColon test. It was determined that 4500 subjects would need to be enrolled. Additional assumptions included the estimated prevalence of colorectal cancer at T0 (0.6%), the estimated sensitivity (0.68) and specificity (0.82) at T0, a T1 return rate (between 66% and 80%), the estimated sensitivity (0.50) and specificity (0.88) at T1, and an estimated adherence to follow-up colonoscopy (between 66% and 80%).

Data Collection The primary endpoints are

the proportion of participants at T1 with a positive test result, but without colorectal cancer

the proportion of subjects at the first screening (T0) with a positive test result, but without colorectal cancer

colorectal cancer detection via Epi proColon test at T1 in patients tested negative via Epi proColon at T0.

The secondary endpoints are

the cumulative probability of cancer detection

the cumulative probability of a false referral

the probability of testing negative at both time points

the adherence to Epi proColon at both screenings (i.e., T0, T1)

the diagnostic yield

the adherence to follow-up diagnostic colonoscopy after a positive Epi proColon test

the assay failure rate

adverse events related to blood draw

adverse events related to diagnostic colonoscopy

Follow-up Visits and Length of Follow-up Subjects will be followed for up to 21 months.


OSB Lead-Epi proColon PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/11/2016 12/13/2016 Overdue/Received
one year report 04/12/2017 04/12/2017 On Time
18 month report 10/11/2017 10/17/2017 Overdue/Received
two year report 04/12/2018    
three year report 04/12/2019    
four year report 04/11/2020    
five year report 04/11/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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