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The Obalon Balloon System - Post-Approval Study is a prospective, observational, and 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obalon Balloon System | Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obalon Balloon System | Device | Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Event | Device or Procedure related Serious Adverse Event | 6-Month |
| Percentage of Patients with at least 5% TBWL | Percentage of Patients with at least 5% TBWL | 6-Month |
| Mean % TBWL | Mean %TBWL | 6-Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shelby Sullivan, MD, FACG | University of Colorado, Denver | Principal Investigator |
| Rachel Moore, MD, FACS, FASMBS | Surgical Specialist of Louisiana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smart Dimensions Weight Loss | Fountain Valley | California | 92694 | United States | ||
| Davtyan Medical Weight Loss and Wellness |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Glendale |
| California |
| 91202 |
| United States |
| Lifetime Surgical Weight Loss | Los Gatos | California | 95032 | United States |
| SkyLex Health | Santa Monica | California | 90404 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Surgical Specialists of Louisiana | Metairie | Louisiana | 70001 | United States |
| New Jersey Bariatric Center | Springfield | New Jersey | 07081 | United States |
| Greenwich Village Gastroenterology | Poughkeepsie | New York | 12601 | United States |
| New York Bariatric Group | Roslyn Heights | New York | 11577 | United States |
| JourneyLite Physicians | Cincinnati | Ohio | 45241 | United States |
| Artisan Cosmetic Surgery | Toledo | Ohio | 43617 | United States |
| Minimally Invasive Surgical Associates | Dallas | Texas | 75208 | United States |
| Snow Bariatic Center | Flower Mound | Texas | 75028 | United States |
| Ultimate Bariatrics | Fort Worth | Texas | 76102 | United States |
| Bariatric Medical Institute of Texas | San Antonio | Texas | 78258 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |