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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160001 S003/ PAS001 |
| Date Original Protocol Accepted |
07/19/2017
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| Date Current Protocol Accepted |
08/08/2019
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| Study Name |
Obalon Balloon System PAS
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| Device Name |
OBALON BALLOON SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
*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.
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| Study Population |
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.
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| 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.
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| Key Study Endpoints |
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.
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| 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.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
201 Subjects
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| Actual Number of Sites Enrolled |
18 sites
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| 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).
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| 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.
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| 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).
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| Study Strengths & Weaknesses |
Strengths: Large enough sample size of sites (18) and patients (201)
Weaknesses: No concomitant comparator group
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| Recommendations for Labeling Changes |
Yes, the results of the post-approval study must be included in the labeling.
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