Overweight
Conditions
Keywords
BMI classification-overweight
Brief summary
The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.
Interventions
PROCEDURECO2
CO2 treatment delivered to randomized flank at each study visit
PROCEDURESham
Sham treatment to other flank at each study visit
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of flank circumference | 6 months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed