NCT01517646

Brief Summary

This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

June 22, 2017

Status Verified

January 1, 2012

Enrollment Period

2.7 years

First QC Date

January 4, 2012

Last Update Submit

June 20, 2017

Conditions

Body Fat Disorder

Keywords

LipolysisCryolipolysisFat Reduction

Outcome Measures

Primary Outcomes (1)

  • Efficacy Assessment through Ultrasound Measurements

    The primary endpoint will be analyzed by percent reduction in fat layer thickness, as measured by ultrasound. • Safety endpoint: incidence of device- or procedure-related adverse events. Acceptance criteria - zero incidences of UADEs.

    16 weeks post final treatment

Secondary Outcomes (1)

  • Outcome Measured by Photo Review and Subject Satisfaction Questionnaire

    16 weeks post final treatment

Study Arms (1)

Fat Reduction

NO INTERVENTION
Device: The Zeltiq System

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
Fat Reduction

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects \> 18 years of age and \< 65 years of age.
  • Subject has clearly visible fat on intended treatment area(s), which in the investigator's opinion, may benefit from the treatment(s). Treatment areas include: abdomen, saddlebag (outer aspect of upper thighs), upper arms and inner thighs.
  • Subject has not had weight change exceeding 10 pounds in the preceding month.
  • Subject with body mass index (BMI) between 25 and 35. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
  • Subject agrees to maintain his/her 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 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 is taking or has taken diet pills or supplements within the past month.
  • Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
  • Subject is pregnant or intending to become pregnant in the next 8months.
  • 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.
  • Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arbutus Laser Centre

Vancouver, British Columbia, V6J IZ6, 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
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 25, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 22, 2017

Record last verified: 2012-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)