Study of the Carbon Dioxide Treatment for Fat Reduction
Status: | Active, not recruiting |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 2/17/2019 |
Start Date: | January 2010 |
End Date: | December 2019 |
A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction
The primary objective of this study is to demonstrate the efficacy and safety of the carbon
dioxide for subcutaneous fat reduction.
dioxide for subcutaneous fat reduction.
Inclusion criteria:
- Male or female subject ages ≥ 18 years old
- Body mass index (BMI) between 18.5-24.99. (BMI is defined as weight in pounds
multiplied by 703 divided by the square of the height in inches).
Subject in good health
- Willing and able to abstain from partaking in any treatment other than the study
procedure (existing or new) to promote body contouring and/or weight loss during the
course of study participation.
- Subject agrees to maintain their weight (i.e. within 5 pounds) by not making any
changes to diet or lifestyle during the study.
- The subject has the willingness and the ability to understand and provide informed
consent for the use of their tissue and communicate with the investigator
Exclusion criteria:
- Pregnant or lactating or intends to become pregnant in the next 9 months.
- Unable to understand the protocol or to give informed consent
- Any previous and/or pending procedures at the treatment area or that may likely affect
the treatment area
- Pending and/or anticipated major change in diet or exercise pattern in the six weeks
following the last treatment or who has taken diet pills within the last 6 months.
- History of asthma or chronic obstructive pulmonary diseases
- Active skin disease or skin infection in the treatment area
- Bleeding tendency or coagulopathy
- Subject who are allergic to lidocaine
- Any other condition that would, in the professional opinion of the investigator,
potentially affect response or participation in the clinical study, or would pose as
an unacceptable risk to the subject
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