Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Abdominal Fat Using the eZ App Large Applicator

NCT01318343 | Completed DMC

• 1 other identifier: LSSC Zeltiq eZ App 8
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of single treatment vs. multiple treatments of CoolSculpting™ by Zeltiq™ Aesthetics for non-invasive cooling of subcutaneous fat using the eZ App 8 large applicator on the abdomen for fat layer reduction.

Conditions

Abdominal Fat; Adipose Tissue, Abdominal

Keywords

Cryolipolysis; Abdominal Fat; Adipose Tissue; Fat Reduction; Non Invasive

Study Arms (3)

Treatment Group 1

Eight (8) subjects will receive one (1) treatment with the eZ8 Large Applicator.

Treatment Group 2

Eight (8) subjects will receive two (2) treatments two (2) months apart with the eZ8 Large Applicator.

Treatment Group 3

Four (4) subjects will receive one (1) treatment, six (6) months after the previous treatment with the eZ App 8 large applicator to the abdomen. This is the same applicator that is being evaluated in this study. These subjects have been treated on-site at the Laser \& Skin Surgery Center of New York by the study doctor.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of 20 subjects, ages 18-65 years, who have clearly visible fat in the lower abdomen and are appropriate candidates as per the Study Doctor's physical examination.

You may qualify if:

• Male or female between the ages of 18 and 65 years of age.
• Clearly visible fat on an area of the lower abdomen appropriate for treatment with the non-invasive Zeltiq cooling device.
• Not had weight change fluctuations exceeding 5 pounds in the preceding 6 months.
• Read and sign a written informed consent form.

You may not qualify if:

• Had liposuction, or another surgical procedure(s) or mesotherapy (injections of minute natural extracts, drugs and other agents into the skin to eliminate fat deposits in cellulite) in area of intended treatment within the past 2 years.
• Known history of injections into the abdomen (e.g., cortisone) within the past 6 months.
• Known history of cryoglobulinemia (abnormal blood proteins that thicken in cold temperatures), cold urticaria (large, allergic hives that occur when the skin is exposed to cold), or paroxysmal cold hemoglobinuria (sudden development of red blood cell breakdown causing hemoglobin \[protein compound in blood\] in the urine).
• Used diet pills within the past 6 months.
• Taking amino- or theophylline for asthma.
• You are unable or unwilling to comply with the study requirements.
• Any dermatological conditions or scars within the location of the treatment site that may interfere with the treatment or evaluation.
• Currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Pregnant or intending to become pregnant in the next 9 months.
• Breastfeeding or have been breastfeeding in the past 9 months.
• Any other condition that would, in the professional opinion of the study doctor, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Sponsors & Collaborators

• Laser and Skin Surgery Center of New York: lead
• Zeltiq Aesthetics: collaborator

Study Sites (1)

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Study Officials

• Roy G Geronemus, MD

  Laser & Skin Surgery Center of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (1)