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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01177787 |
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Date of registration:
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28/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Efficacy of Cryolipolysis on the Fat of Thigh in Korean Women
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Scientific title:
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Clinical Efficacy of Local Fat Reduction on the Thigh of Korean Women Through Cryolipolysis |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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15 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01177787 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Kyu Rae Lee, MD.PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- premenopausal healthy women
- subjects with body mass index >= 18.
- subjects with visible fat on both thigh
- subjects to understand and agree to this study protocol
Exclusion Criteria:
- subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia
- subjects with pregnancy or lactation within 6 months or next 3 months
- subjects with any laboratory, or metabolic abnormalities
- uncooperative subjects to comply with the study protocol
- women taking any medication over 6 months
- subjects with menstrual irregularities
- subjects to change over 10% of the former weight within the past 6 months - any
procedure such as liposuction, or another surgical procedure or mesotherapy to reduce
fat within 6 months
- subjects with any dermatologic abnormalities on the target area (thigh)
- subjects with any injection into the area of intended treatment (e.g. cortisone)
within 6 months
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Lipolysis
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Intervention(s)
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Device: electrical stimulation
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Device: zeltiq
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Primary Outcome(s)
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clinical efficacy of fat reduction on thigh by femoral CT
[Time Frame: 1 month]
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Secondary Outcome(s)
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clinical efficacy/safety of fat reduction through cryolipolysis
[Time Frame: 3 months]
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Secondary ID(s)
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Wonik201007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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