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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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Obalon Balloon System PAS

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Study Status Completed
Application Number P160001 S003/ PAS001
Date Current Protocol Accepted 08/08/2019
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 *Please Note: P160001 and P160001/S003 are bundled*
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
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 15 sites in the United States. A total of 200 subjects will be enrolled, 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
Actual Number of Patients Enrolled 201 Subjects
Actual Number of Sites Enrolled 18 sites
Patient Follow-up Rate 201 (100% completed phase I of the study (end of balloon therapy).
180 (89.6%) completed phase II (1-Year Follow-up).
Final Safety Findings All Adverse Events: 879 in 167 subjects.
Serious Adverse Events: 0 device/procedure related; 1 Not Device/procedure related.
Most of the adverse events (94.2%) are classified as mild. The most common reported adverse events are nausea (76.6%), retching (48.8%), vomiting (41.8%), and abdominal pain (16.9%). The other reported adverse events are observed in less than 10% of subjects.

Final Effect Findings Weight loss data from 197 (98%) of the subjects that completed balloon therapy subjects is included in the results.
Four (4) subjects were lost to follow-up.
The mean weight loss results were 20.3 lbs. and 9.4% TBL. The mean weight loss results were higher compared to the pivotal SMART Study (14.4 lbs. and 6.6% TBL).
Study Strengths & Weaknesses Strengths: Large enough sample size of sites (18) and patients (201)
Weaknesses: No concomitant comparator group

Recommendations for Labeling Changes Yes, the results of the post-approval study must be included in the labeling.

Obalon Balloon System PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/24/2017 09/11/2017 On Time
one year report 03/09/2018 03/07/2018 On Time
18 month report 09/08/2018 09/05/2018 On Time
interim report 03/07/2019 03/07/2019 On Time
two year report 09/08/2019 09/06/2019 On Time
interim report 03/07/2020 03/06/2020 On Time
three year report 09/07/2020 09/30/2020 Overdue/Received
final report 11/08/2021 10/29/2021 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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