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Completed

NCT Number: NCT00974415

Study of the Carbon Dioxide Treatment for Fat Reduction

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2

Procedure

CO2 treatment delivered to randomized flank at each study visit

Sham

Procedure

Sham treatment to other flank at each study visit

Primary outcomes

  1. Reduction of flank circumference

    Time frame: 6 months

Secondary outcomes

  1. 10-point pain visual analog scale

    Time frame: 4 weeks

  2. Any adverse events

    Time frame: 6 months

  3. Patient satisfaction, determined by using patient satisfaction questionnaires.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2009
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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