Study of the Carbon Dioxide Treatment for Fat Reduction

Overweight Clinical Trial

Official title:

A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00974415
• Other study ID #: STU11387
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

Procedure:
• CO2
CO2 treatment delivered to randomized flank at each study visit
• Sham
Sham treatment to other flank at each study visit

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of flank circumference		6 months
Secondary	10-point pain visual analog scale		4 weeks
Secondary	Any adverse events		6 months
Secondary	Patient satisfaction, determined by using patient satisfaction questionnaires.		6 months