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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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12 December 2020 |
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Main ID: |
NCT01673113 |
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Date of registration:
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22/08/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis
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Scientific title:
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Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01673113 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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R. Rox Anderson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects ages 18-65 years old, male or female with visible adiposity on the flanks
(love handles) and no weight changes exceeding 10lb during the preceding month.
- Willingness to participate in the study
- Informed consent agreement signed by the subject
- Willingness to follow the treatment schedule and post treatment care requirements
- Willingness to have skin biopsy done
- No history of allergy to lidocaine or any other anesthetics.
Exclusion Criteria:
- Subject has a history of nerve problems, neuropathy
- Subject who has recently undergone liposuction or another weight loss procedure, had a
history of subcutaneous injections into the area of intended treatment within the
preceding 6 months.
- Subjects with history of diabetes
- Subjects with a BMI of 30 or greater
- Subject has an infection, surgical scars or other dermatologic condition in the area
to be treated
- Subject has known cold sensitivity disorders including Raynaud's phenomena, cold
urticaria, cryoglobulinemia, or cold induced hemoglobinuria
- Women who are pregnant or intending to become pregnant in the following 9 months;
women who are lactating or had been lactating in the prior 9 months.
- Subject is immunosuppressed
- Subject is unable to comply with treatment, home care or follow-up visits
- Subject has a history of vitiligo
- Subject has a history of keloid formation
- Subject is currently enrolled in a clinical study of any other unapproved
investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the
investigator, potentially affect the subject's response or the integrity of the data
or would pose an unacceptable risk to the subject.
- Subject taking anticoagulants
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adiposity
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Intervention(s)
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Device: Zeltiq CoolSculpting device
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Primary Outcome(s)
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Vibration Detection Threshold (VDT)
[Time Frame: within 48-72 hours after treatment]
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Secondary Outcome(s)
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Mechanical Detection Threshold (MDT)
[Time Frame: 48-72 hours post treatment]
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Secondary ID(s)
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2012-P-001380
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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