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Study of the Carbon Dioxide Treatment for Fat Reduction

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974415
First Posted: September 10, 2009
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
  Purpose
The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.

Condition Intervention
Overweight Procedure: CO2 Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction

Resource links provided by NLM:


Further study details as provided by Murad Alam, Northwestern University:

Primary Outcome Measures:
  • Reduction of flank circumference [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
CO2 treatment
Procedure: CO2
CO2 treatment delivered to randomized flank at each study visit
Sham Comparator: sham
sham treatment
Procedure: Sham
Sham treatment to other flank at each study visit

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974415


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
Study Chair: Dennis P West, PhD Northwestern University
  More Information

Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00974415     History of Changes
Other Study ID Numbers: STU11387
First Submitted: September 9, 2009
First Posted: September 10, 2009
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Murad Alam, Northwestern University:
BMI classification-overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms