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NCT01673113 · ClinicalTrials.gov registry record · NA
Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01673113: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01673113 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01673113, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
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.
Primary Outcome
VDT was evaluated using a computerized vibrometer with 1cm2 contact probe placed perpendicularly on the skin (TSA-II, Medoc Inc., Ramat Yishai, Israel). This device gradually increased the vibration magnitude until the subject pressed a "stop" button to indicate when they first felt the vibration. This test was repeated 8 times. The values presented in the data table were averaged over all repeats.
Interventions
- DEVICE Zeltiq CoolSculpting device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT01673113 record still lists
NCT01673113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Zeltiq CoolSculpting device is the first listed.
NCT01673113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01673113 about?
NCT01673113 is a clinical study titled "Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis". 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. Ther...
What is the current status of trial NCT01673113?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2012-12. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01673113?
The interventions under investigation include: Zeltiq CoolSculpting device (DEVICE).
Who is sponsoring clinical trial NCT01673113?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01673113's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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