Obalon Balloon System Post-Approval Study
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 3/17/2019 |
| Start Date: | June 15, 2018 |
| End Date: | June 30, 2020 |
| Contact: | Amy VandenBerg |
| Email: | ClinicalAffairs@obalon.com |
| Phone: | 760.795.6551 |
Obalon Balloon System - Post-Approval Study
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and
multi-center study.
multi-center study.
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in
conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued
WLBM program after balloon removal
conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued
WLBM program after balloon removal
Inclusion Criteria:
- At least 22 years old
- BMI of 30-40 kg/m2
Exclusion Criteria:
- Contraindicated for the device
- Use of medications or medical devices known to induce weight gain or weight loss
within the preceding 6 months.
- Known history of endocrine disorders affecting weight.
- Participation in any clinical study which could affect weight loss within the past
year
- 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
- Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical
condition, in the opinion of the investigator
We found this trial at
14
sites
Roslyn Heights, New York 11577
Principal Investigator: Shawn M Garber, MD, FACS, FASMBS
Phone: 800-633-8446
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13001 E. 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Shelby Sullivan, MD, FACG
Phone: 303-724-6070
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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10475 Reading Road
Cincinnati, Ohio 45241
Cincinnati, Ohio 45241
Principal Investigator: Trace W Curry, MD
Phone: 517-475-3663
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Dallas, Texas 75208
Principal Investigator: Sachin S Kukreja, MD, FACS, FASMBS
Phone: 460-620-0223
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Fort Worth, Texas 76102
Principal Investigator: Adam B Smith, DO, FACOS
Phone: 817-850-1100
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18111 Brookhurst Street
Fountain Valley, California 92708
Fountain Valley, California 92708
Principal Investigator: Michael Russo, MD
Phone: 714-861-4666
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Glendale, California 91202
Principal Investigator: David G Davtyan, MD, FACS, FICS
Phone: 818-546-1500
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Los Gatos, California 95032
Principal Investigator: Richard T Nguyen, DO, FACS, FACOS
Phone: 403-358-1855
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Metairie, Louisiana 70001
Principal Investigator: Rachel Moore, MD, FACS, FASMBS
Phone: 877-856-6096
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Poughkeepsie, New York 12601
Principal Investigator: Anthony A Starpoli, MD
Phone: 845-471-1354
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9502 Huebner Road
San Antonio, Texas 78240
San Antonio, Texas 78240
Principal Investigator: Michael V. Seger, MD
Phone: 210-610-8924
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Santa Monica, California 90404
Principal Investigator: Carson D Liu, MD, FACS
Phone: 310-507-9205
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Springfield, New Jersey 07081
Principal Investigator: Ajay Goyal, MD, FACS
Phone: 908-481-1270
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Trophy Club, Texas 76262
Principal Investigator: Robert G Snow, DO, FACOS
Phone: 817-520-5411
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