Status:
ACTIVE_NOT_RECRUITING
Study of the Carbon Dioxide Treatment for Fat Reduction
Lead Sponsor:
Northwestern University
Conditions:
Overweight
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00974415
Start Date
January 1 2010
End Date
December 1 2025
Last Update
January 30 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611