NCT00762437

Brief Summary

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

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

Study Start

First participant enrolled

January 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2009

Completed
15.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

September 27, 2008

Results QC Date

April 7, 2025

Last Update Submit

May 7, 2025

Conditions

Reduction of Unwanted Fat

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Visible Improvement in Treated Area

    Investigator assessment to document any visible improvement in the treatment area.

    4 months

Secondary Outcomes (1)

  • Participant Satisfaction

    4 months

Study Arms (1)

Treatment Group

EXPERIMENTAL
Device: Zeltiq Dermal Cooling Device

Interventions

Zeltiq Dermal Cooling DeviceDEVICE

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

Treatment Group

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects \> 18 years of age.
  • Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back.
  • Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months.
  • Subject has read and signed a written informed consent form.

You may not qualify if:

  • Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
  • Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
  • Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  • Subject has used diet pills within the past 6 months.
  • Subject is unable or unwilling to comply with the study requirements.
  • Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
  • Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  • Patient is pregnant or intending to become pregnant in the next 9 months.
  • Patient is lactating or has been lactating in the past 9 months.
  • Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Investigational Site

Sacramento, California, United States

Location

Investigational Site

San Diego, California, United States

Location

Investigational Site

Washington D.C., District of Columbia, United States

Location

Investigational Site

Miami, Florida, United States

Location

Investigational Site

Chicago, Illinois, United States

Location

Investigational Site

Baltimore, Maryland, United States

Location

Investigational Site

Boston, Massachusetts, United States

Location

Investigational Site

Minneapolis, Minnesota, United States

Location

Investigational Site

Hackensack, New Jersey, United States

Location

Investigational Site

New York, New York, United States

Location

Investigational Site

Dallas, Texas, United States

Location

Results Point of Contact

Title
Sally Hallas, RN
Organization
AbbVie
sally.hallas@abbvie.com
209-294-5571

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2008

First Posted

September 30, 2008

Study Start

January 1, 2008

Primary Completion

November 17, 2009

Study Completion

December 18, 2009

Last Updated

May 25, 2025

Results First Posted

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(11)