Study of the Carbon Dioxide Treatment for Fat Reduction

Northwestern University

Status: Active, not recruiting

Conditions: Overweight

Treatments: Procedure: Sham; Procedure: CO2

Study type: Interventional

Funder types: Other

Identifiers

NCT00974415

STU11387

Details and patient eligibility

About

The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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25 participants in 2 patient groups

treatment

Experimental group

Description:

CO2 treatment

Treatment:

Procedure: CO2

sham

Sham Comparator group

Description:

sham treatment

Treatment:

Procedure: Sham