Overview

This trial is active, not recruiting.

Condition overweight
Treatments co2, sham
Sponsor Northwestern University
Start date January 2010
End date December 2016
Trial size 25 participants
Trial identifier NCT00974415, STU11387

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
CO2 treatment
co2
CO2 treatment delivered to randomized flank at each study visit
(Sham Comparator)
sham treatment
sham
Sham treatment to other flank at each study visit

Primary Outcomes

Measure
Reduction of flank circumference
time frame: 6 months

Secondary Outcomes

Measure
10-point pain visual analog scale
time frame: 4 weeks
Any adverse events
time frame: 6 months
Patient satisfaction, determined by using patient satisfaction questionnaires.
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction
Principal investigator Murad Alam, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Northwestern University.