Study of the Carbon Dioxide Treatment for Fat Reduction

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction

Conditions
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Overweight

Intervention / Treatment
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* Procedure: CO2
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>CO2 treatment | Procedure: CO2<br>* CO2 treatment delivered to randomized flank at each study visit<br>|
| Sham Comparator: sham<br>sham treatment | Procedure: Sham<br>* Sham treatment to other flank at each study visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of flank circumference |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI classification-overweight