Study of the Carbon Dioxide Treatment for Fat Reduction

This study has been completed.

First Received on September 9, 2009. Last Updated on May 25, 2011 History of Changes

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00974415

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 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:

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Reduction of waist circumference, waist to hip ratio [ 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:	5
Study Start Date:	January 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: treatment CO2 treatment	Procedure: CO2 CO2 treatment delivered to half of the abdomen at each study visit

Eligibility

Criteria

Inclusion Criteria:

Age 18-60 years old
Body mass index between 25-34.99
The subjects are in good health
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
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 following six weeks
History of asthma or chronic obstructive pulmonary diseases
Active skin disease or skin infection in the treatment area
Bleeding tendency or coagulopathy
Taking the following prescription medications:
- Anticoagulation of any type including baby aspirin, vitamin E and Ginkgo biloba
- Subject who allergic to lidocaine

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, Northwestern University
ClinicalTrials.gov Identifier:	NCT00974415 History of Changes
Other Study ID Numbers:	MA-STU11387
Study First Received:	September 9, 2009
Last Updated:	May 25, 2011
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 February 09, 2012