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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Open Label Post Market Registry in Clinical Practi


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General
Application Number P080009 / PAS002
Current Plan Approved 03/25/2015
Study Name Open Label Post Market Registry in Clinical Practi
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is an observational, single arm, non-randomized, non-blinded, multi-center, prospective, safety study of sedation with the SEDASYS System during colonoscopy and EGD, performed in routine clinical practice.
Study Population Description Adult patients who satisfy the approved FDA labeling and are scheduled for non-emergent endoscopy procedures, including those from PAS I (CI-13-000X)
Sample Size 7430 patients; including subject population (approximately 866) from CI-13-000X (PAS I). This sample size will allow confidence of 99% that the rate is less than 1/1,000 (allowing for one anesthesia professional rescue intervention). No dropouts are anticipated.

There will be 40 - 60 trained users at up to 30 sites

Cases per Trained User 120-320

Cases per Institution 240-720

Anesthesia Professional Rescue Interventions per Trained User: <=1

Anesthesia Professional Rescue Interventions per Institution: <=1

Data Collection Primary: Total number of anesthesia professional rescue interventions <=1

Secondary: Subjects sedated requiring BMV and/or AAI Safety:

The incidence of adverse events (AEs) will be assessed at the preferred term (PT) level using the Medical Dictionary for Regulatory Activities (MedDRA) for event categorization. Incidence of AEs will also be assessed by 1) onset time with respect to alarm condition; 2) relationship to endoscopic procedure (Colonoscopy or EGD); 3) relationship to the device (alarm response); and 4) severity.

Follow-up Visits and Length of Follow-up Adult male and female subjects who satisfy the approved FDA labeling and are scheduled for non-emergent endoscopy procedures during the study timeframe will be invited to participate in the study. Patients will be enrolled with informed consent including those from companion study (CI-13-000X).

Visit 1: Screening.

Visit 2: Pre-procedure <=15 days of the procedure(Visit 1 (screening) and Visit 2 (procedure) could occur on the same day).

Length of Follow-up

1-day per patient.
Final Study Results
Number of Patients n/a
Number of Sites n/a
Follow-up Rate n/a
Safety Findings n/a
Effect Findings n/a
Strengths & Weaknesses n/a
Label Changes no


Open Label Post Market Registry in Clinical Practi Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/01/2013 12/16/2013 Overdue/Received
one year report 05/03/2014 05/02/2014 On Time
18 month report 11/01/2014 10/30/2014 On Time
two year report 05/03/2015 04/23/2015 On Time
three year report/Final Report 05/03/2016 05/03/2016 On Time


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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