NCT01377740

Brief Summary

This study is being performed to reduce unwanted abdominal fat using two different applicators for the Zeltiq System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 22, 2017

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

June 16, 2011

Last Update Submit

June 20, 2017

Conditions

Fat Reduction in the Abdomen

Keywords

LipolysisCryolipolysisFat Reduction

Outcome Measures

Primary Outcomes (1)

  • Independent imaging review

    The primary effectiveness endpoint is the percent of reviews by the reviewers which either identify no clinically significant difference in fat reduction between the two sides of the abdomen, or identify greater fat reduction on the side of the abdomen treated with the CoolFlex applicator at 8 weeks post-treatment. It is expected that the percentage of reviews identifying no clinically significant difference between the two sides of the abdomen or identifying greater fat reduction on the side of the abdomen treated with the CoolFlex applicator at 8 weeks post-treatment will be at least 75%.

    16 weeks

Secondary Outcomes (2)

  • Overall reduction

    16 weeks

  • Subject satisfaction

    16 weeks

Interventions

The Zeltiq SystemDEVICE

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Also known as: Cryolipolysis, Lipolysis

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subjects \> 18 years of age and \< 65 years of age.
  • Subject has clearly visible fat on the abdomen. (Figure 1)
  • Subject has not had weight change exceeding 10 pounds in the preceding month.
  • Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
  • Subject has read and signed a written informed consent form.

You may not qualify if:

  • Subject has had a surgical procedure(s) in the area of intended treatment.
  • Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
  • Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
  • Subject has discernable asymmetry or contour irregularity in the intended treatment area.
  • Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
  • Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  • Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
  • Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  • Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
  • Subject is taking or has taken diet pills or supplements within the past month.
  • Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
  • Subject is pregnant or intending to become pregnant in the next 6 months.
  • Subject is lactating or has been lactating in the past 6 months.
  • Subject is unable or unwilling to comply with the study requirements.
  • Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arbutus Laser Centre

Vancouver, British Columbia, V6J IZ6, Canada

Location

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Gerald Boey, MD

    Arbutus Laser Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 21, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 22, 2017

Record last verified: 2012-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)