Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis
This study is currently recruiting participants.
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01673113
First received: August 22, 2012
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
Cryolipolysis with Zeltiq CoolSculpting device is a novel method of non-invasive fat removal. The technique works by application of cold plates to the skin surface for a single cooling cycle lasting 60 minutes, after which a cold-induced inflammatory panniculitis leads to selective loss of fat. There is no histologic evidence of necrotic or inflammatory damage to skin or nerves, however a single small human study has reported prolonged temporary altered sensation (hypoesthesia) in the area of cryolipolysis procedure. This hypoesthesia seen in about 2/3 of patients, is completely reversible, lasts up to 8 weeks after treatment, and suggests that cooling under these conditions can temporarily alter sensory nerve function.
The purpose of this study is to further characterize the reversible cutaneous sensory function alteration after cryolipolysis with Zeltiq CoolSculpting device. Using multiple modalities of sensory nerve function we hope to elucidate the details of cryolipolysis induced sensory nerve alteration.
| Condition | Intervention | Phase |
|---|---|---|
|
Cryolipolysis Using Zeltiq CoolSculpting Device and Sensory Nerve Function Analysis |
Device: Zeltiq CoolSculpting device |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Characterize sensory nerve function alteration by detailed sensory neurologic exam and quantitative sensory function tests [ Time Frame: within 48-72 hours after treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cryolipolysis |
Device: Zeltiq CoolSculpting device
This is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks, an area commonly referred to as the "love handles."
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673113
Contacts
| Contact: R. Rox Anderson, MD | 617-724-4937 |
Locations
| United States, Massachusetts | |
| Wellman Center for Photomedicine, MGH | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Lilit Garibyan, MD, PhD lilitg@gmail.com | |
| Contact: Beverly Damin 617-724-4937 | |
| Principal Investigator: R. Rox Anderson, MD | |
Sponsors and Collaborators
Massachusetts General Hospital
More Information
No publications provided
| Responsible Party: | Richard Rox Anderson, MD, Professor, Harvard Medical School, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01673113 History of Changes |
| Other Study ID Numbers: | 2012-P-001380 |
| Study First Received: | August 22, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
cryolipolysis, sensory nerve function, Zeltiq |
ClinicalTrials.gov processed this record on May 19, 2013