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The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | CO2 treatment |
|
| sham | Sham Comparator | sham treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 | Procedure | CO2 treatment delivered to randomized flank at each study visit |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of flank circumference | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 10-point pain visual analog scale | 4 weeks | |
| Any adverse events | 6 months | |
| Patient satisfaction, determined by using patient satisfaction questionnaires. |
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Inclusion criteria:
Subject in good health
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham |
| Procedure |
Sham treatment to other flank at each study visit |
|
| 6 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |