Study of the Carbon Dioxide Treatment for Fat Reduction
This study is ongoing, but not recruiting participants.
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00974415
First received: September 9, 2009
Last updated: January 15, 2013
Last verified: January 2013
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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 Northwestern University:
Primary Outcome Measures:
- Reduction of thigh circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 10-point pain visual analog scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Any adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Patient satisfaction, determined by using patient satisfaction questionnaires. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment
CO2 treatment
|
Procedure: CO2
CO2 treatment delivered to thigh at each study visit
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Murad Alam, Professor of Dermatology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00974415 History of Changes |
| Other Study ID Numbers: | STU11387 |
| Study First Received: | September 9, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
BMI classification-overweight |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013