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Study of the Carbon Dioxide Treatment for Fat Reduction

Primary Purpose

Overweight

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO2
Sham
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring BMI classification-overweight

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

treatment

sham

Arm Description

CO2 treatment

sham treatment

Outcomes

Primary Outcome Measures

Reduction of flank circumference

Secondary Outcome Measures

10-point pain visual analog scale
Any adverse events
Patient satisfaction, determined by using patient satisfaction questionnaires.

Full Information

First Posted
September 9, 2009
Last Updated
February 17, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00974415
Brief Title
Study of the Carbon Dioxide Treatment for Fat Reduction
Official Title
A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
BMI classification-overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
CO2 treatment
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
sham treatment
Intervention Type
Procedure
Intervention Name(s)
CO2
Intervention Description
CO2 treatment delivered to randomized flank at each study visit
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Sham treatment to other flank at each study visit
Primary Outcome Measure Information:
Title
Reduction of flank circumference
Time Frame
6 months
Secondary Outcome Measure Information:
Title
10-point pain visual analog scale
Time Frame
4 weeks
Title
Any adverse events
Time Frame
6 months
Title
Patient satisfaction, determined by using patient satisfaction questionnaires.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis P West, PhD
Organizational Affiliation
Northwestern University
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Study of the Carbon Dioxide Treatment for Fat Reduction

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