Back to resultsPilot Study of CoolTXT for Non-Invasive Fat Reduction
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Zeltiq System
Sponsored by
About this trial
This is an interventional other trial for Body Fat Disorder focused on measuring Lipolysis, Cryolipolysis, Fat Reduction
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 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 (stretch marks is not an exclusion).
- 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.
Sites / Locations
- Arbutus Laser Centre
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Fat Reduction
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Outcome Measured by Photo Review and Subject Satisfaction Questionnaire
Comparison of pre- and 16-week post final treatment photographs of the treatment area(s).
Subject satisfaction as assessed by questionnaires administered at 16 weeks post final treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01517646
Brief Title
Pilot Study of CoolTXT for Non-Invasive Fat Reduction
Official Title
Pilot Study of CoolTXT for Non-Invasive Fat Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.
Detailed Description
The purpose of this study is to evaluate the safety and feasibility of a new product under development for non-invasive fat reduction. The new product delivers controlled cooling via a conformable surface applicator, rather than the existing vacuum applicator. A range of treatment parameters will be investigated. At the investigator's discretion, each treatment area may receive up to 3 treatments, spaced 2 - 8 weeks apart. The subjects will return for follow-up at 2 months and 4 months after final treatment. Therefore, the entire study period may last up to 8 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fat Reduction
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
The Zeltiq System
Other Intervention Name(s)
Cryolipolysis, Lipolysis
Intervention Description
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Primary Outcome Measure Information:
Title
Efficacy Assessment through Ultrasound Measurements
Description
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.
Time Frame
16 weeks post final treatment
Secondary Outcome Measure Information:
Title
Outcome Measured by Photo Review and Subject Satisfaction Questionnaire
Description
Comparison of pre- and 16-week post final treatment photographs of the treatment area(s).
Subject satisfaction as assessed by questionnaires administered at 16 weeks post final treatment.
Time Frame
16 weeks post final treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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 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 (stretch marks is not an exclusion).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Boey, MD
Organizational Affiliation
Arbutus Laser Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arbutus Laser Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6J IZ6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Study of CoolTXT for Non-Invasive Fat Reduction
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