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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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PATHWAY Clinical Trial PAS


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General
Study Status Completed
Application Number P150024 / PAS001
Study Name PATHWAY Clinical Trial PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohorts
Study Population Description Subjects who are active participants in the PATHWAY pivotal trial under G120045
Sample Size 46 subjects are currently enrolled in the study
Data Collection n/a
Follow-up Visits and Length of Follow-up 2 years post device explant

Bi-monthly for six months and at one and two years
Interim or Final Data Summary
Actual Number of Patients Enrolled 31 patients
Actual Number of Sites Enrolled 7 sites
Patient Follow-up Rate Year 3 - 73%, year 4 - 50%, year 5 - 33%
Final Safety Findings 11 adverse events in 11 patients were reported during the postapproval study (10 device related, and 1 procedure related. Four of these 11 adverse events were “Persistent fistula.” Only one serious adverse event classified as “A-Tube dislodgement” was reported.

There were not eating disorders reported during the post approval study.

Final Effect Findings The efficacy of the device while implanted was assessed by percent excess weight loss (%EWL) and total body loss (%TBL). Other efficacy study endpoints while the device was implanted included the change in obesity-related comorbidities (blood pressure, lipid levels,

triglycerides, Hemoglobin A1c or HbA1c) and change in medications.

%EWL: The results ranged from 44.7% on the third year of follow-up, 50.8% in the fourth year and 64.8%

in the fifth or last year.

%EWL Post-Explant: The results ranged from 24.0% at 2-months of follow-up, 27.1% at 4-months, 20.0%

at 6-months, 9.8% at 1-year and 4.5% at 2 years post-explant.

%TBL: The results ranged from 16.6% on the third year of follow-up, 18.7% in the fourth year and 24.3%

in the fifth or last year.

%TBL Post-explant: The results ranged from 8.9% at 2-months of follow-up, 9.8% at 4-months, 7.2% at 6-

months, 3.5% at 1-year and 1.3% at 2 years post-explant.

Co-morbidities:

SBP: The average systolic blood pressure decreased from 124.4 (mmHg) on the third year of follow-up,

116.3 in the fourth year and 117.8 in the fifth or last year.

DBP: The average diastolic blood pressure slightly decreased from 77.6 (mmHg) on the third year of

follow-up, 77.0 in the fourth year and 73.7 in the fifth or last year.

HbA1c: This laboratory measurement was only reported from one patient for years 3 and 4 of the

follow-up, being 5.6 for the third year and 5.4 for the fourth year.

Quality of Life (IWQOL):

Seven patients completed the first-year and three completed the second-year post-explant follow-up

milestones. When compiled, the standardized average quality of life scores at year 1 and 2 post-explant improved from baseline by about 19%.

Eating Disorders (EDE):

Seven patients completed the 1-year post-explant follow-up milestone to date, and three completed the 2-year post explant follow-up. Testing showed no signs of eating disorders.
Study Strengths & Weaknesses Strength: long follow-up. Weaknesses: small sample size, low follow-up rate, and there is no comparator group.
Recommendations for Labeling Changes Yes, the results of the post-approval study should be included.


PATHWAY Clinical Trial PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/13/2016 12/14/2016 Overdue/Received
one year report 06/14/2017 06/12/2017 On Time
18 month report 12/13/2017 12/12/2017 On Time
two year report 06/14/2018 06/12/2018 On Time
three year report 06/14/2019 06/12/2019 On Time
final report 07/29/2019 07/29/2019 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

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