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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. 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.
Interventions
- DEVICE Zeltiq CoolSculpting device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01673113
The ClinicalTrials.gov registry entry for NCT01673113 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zeltiq CoolSculpting device is the first listed.
NCT01673113 reports 0 study locations.
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.
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