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Characterization of Transient Alterations of Cutaneous Sensory Nerve Function by Cryolipolysis

NCT01673113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-10-01

Study results available
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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.

Conditions

  • Adiposity

Interventions

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."

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • R. Rox Anderson, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01673113 on ClinicalTrials.gov