• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

Obalon Balloon System PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P160001 / PAS001
Date Current Protocol Accepted 10/18/2019
Study Name Obalon Balloon System 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 Design: New enrollment, prospective, single arm, observational, sequentially enrolling, open label multi-center study.

Objective: The primary objective of the study is to assess the continued safety and performance of the Obalon Balloon System in the commercial setting.

Study Population Description In addition to the patients’ ability to commercially purchase the device, patients shall meet all inclusion criteria and no exclusion criteria to be considered eligible for study enrollment.



Inclusion Criteria

1. Minimum 22 years of age

2. BMI of 30.0-40.0 kg/m2

3. Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet

4. Study enrollment before or within 7 days of the initial balloon administration.



Exclusion Criteria

1. Contraindicated for use of the Obalon Balloon System per Obalon Balloon System,

Instructions for Use (LIT-7500-0011, page 3)

2. Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.

3. Known history of endocrine disorders affecting weight.

4. Participation in any clinical study which could affect weight loss within the past year.

5. Known history or present condition of structural or functional disorders of the

esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett’s esophagus, esophagitis, dysphagia, achalasia,

stricture/stenosis, esophageal varices, diverticula, or any other disorder of the

esophagus.

6. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator.

Sample Size The study will include 16 sites in the United States. A total of 200 subjects will be enrolled. Of the enrolled subjects, 180 are needed with data through 6 months. No single site is allowed to treat more than 15% of the maximum total or 30 patients.
Data Collection Primary and Secondary Endpoints Safety Endpoints

The study primary endpoint is a safety endpoint that evaluates the percentage of

subjects who experience a Serious Adverse Event that is device or procedure related.



Device or Procedure Related Serious Adverse Event Rate

The percentage of subjects who experience a Serious Adverse Event that is device or procedure related will be evaluated.



Effectiveness Endpoints

This trial is designed to evaluate co-secondary effectiveness endpoints comprised of

(1) the mean % TWL and (2) the proportion of subjects achieving at least 5% TWL.



Co-Secondary Endpoint: Mean Percent Total Weight Loss

The mean percent Total Weight Loss (%TWL) will be evaluated as the first portion of the co-primary endpoint. %TWL is calculated as the ratio of a subject’s weight loss to their starting weight as measured on the date of their first course, first administration procedure.



Co-Secondary Endpoint: 5% TWL Responder Rate

The responder rate will be evaluated as the second portion of the co-secondary endpoint. For the purpose of this co-secondary endpoint, a responder is defined as a subject that achieves at least 5% TWL based on their starting weight as measured on the date of receiving their first balloon.

Follow-up Visits and Length of Follow-up 52 weeks.

Patient participation time includes up to 4 weeks for screening, 24 weeks of balloon therapy period and 24 weeks post-balloon removal. Patients will be followed after post-balloon removal regardless of weight loss results during balloon therapy period.

Interim or Final Data Summary
Interim Safety Information Summary of Interim Results

Safety

From a total of non-serious 202 adverse events in 47 (58.8%) patients, 199 are device or procedure related. Most of the adverse events (85.4%) were classified as mild.

The most common reported adverse events were nausea (53.8%), retching (25.0%), vomiting (20.0%) and abdominal pain (17.5%). The other events reported were observed in less than 10% of the patients. Except for retching and anxiety, the AEs rates in this study are lower compared to the observed rates in the pivotal SMART Study. The reported higher rate of retching was 25.6% vs. 0.3% during premarket, and there is one reported event of anxiety compared to zero during the premarket (SMART) Study.

Effectiveness

The preliminary weight loss data is limited (7 patients) with only 5 patients that received the balloon therapy as intended (3 balloons for at least 20 weeks of therapy). The mean weight loss for the 5 patients that received balloon therapy as intended is 16.2 (8.4) lbs and 6.3% (7.7%) TWL. Because of limited data, weight loss comparisons with the SMART Study have not been assessed.
Actual Number of Patients Enrolled Number of subjects enrolled 80 subjects as of 4/4/19

Actual Number of Sites Enrolled Number of study sites enrolled 14 sites as of 3/4/19
Patient Follow-up Rate Follow-up rate 97.6% (80/82)


Obalon Balloon System PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/09/2017 03/08/2017 On Time
one year report 09/08/2017 09/11/2017 Overdue/Received
18 month report 03/09/2018 03/07/2018 On Time
two year report 09/08/2018 09/05/2018 On Time
interim report 03/07/2019 03/07/2019 On Time
three year report 09/08/2019 09/06/2019 On Time
interim report 03/07/2020    
four year report 09/07/2020    
five year report 09/07/2021    


Contact Us

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

Related Links

-
-