- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00974415
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.
Sponsor
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
Keywords
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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