Study of the Carbon Dioxide Treatment for Fat Reduction

January 31, 2024 updated by: Murad Alam, Northwestern University

A Pilot 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
CO2 treatment
CO2 treatment delivered to randomized flank at each study visit
Sham Comparator: sham
sham treatment
Sham treatment to other flank at each study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of flank circumference
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University
  • Study Chair: Dennis P West, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimated)

September 10, 2009

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU11387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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