|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00762307 |
|
Date of registration:
|
27/09/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Non-invasive Cooling of Subcutaneous Fat
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
January 2007 |
|
Target sample size:
|
192 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00762307 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Male or female subjects > 18 years of age.
2. Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding
month.
4. Subject has read and signed a written informed consent form.
Exclusion Criteria:
1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area
of intended treatment within the past 2 years.
2. Subject has a known history of subcutaneous injections into the area of intended
treatment (e.g., cortisone) within the past 6 months.
3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold
hemoglobinuria.
4. Subject is taking diet pills within the past 6 months.
5. Subject is unable or unwilling to comply with the study requirements.
6. Subject has any dermatological conditions or scars within the location of the test
sites that may interfere with the treatment or evaluation.
7. Subject is currently enrolled in a clinical study of any other unapproved
investigational drug or device.
8. Patient is pregnant or intending to become pregnant in the next 9 months.
9. Patient is lactating or has been lactating in the past 9 months.
10. Any other condition or laboratory value that would, in the professional opinion of
the investigator, potentially affect response or participation in this clinical
study, or would pose an unacceptable risk to the subject.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Reduction of Unwanted Fat
|
|
Intervention(s)
|
|
Device: Zeltiq Dermal Cooling Device
|
|
Primary Outcome(s)
|
|
Reduction in the fat layer thickness
[Time Frame: 2 months, 6 months]
|
|
Secondary Outcome(s)
|
|
Subject satisfaction
[Time Frame: 2 months, 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|