Abdominal FatNCT01318343
Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Abdominal Fat Using the eZ App Large Applicator
An observational study of Abdominal Fat and Adipose Tissue, Abdominal, run by Laser and Skin Surgery Center of New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Fat, Adipose Tissue, Abdominal
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Had treatment with a cooling device within the past 6 months. (This exclusion does not apply to those enrolled in Group 3).
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser & Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Subcutaneous Fat of the Abdomen Using the eZ App Large Applicator
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.
Read the detailed description
The Zeltiq Cooling Device to be used in this study (i.e, CLN1) is designed to non-invasively cool skin and subcutaneous fat. The device provides cooling at a controlled preset level (i.e., temperature) as defined by a pre-programmed treatment profile and provides continuous feedback on the temperature of the cooling plate interface with the skin. The device also is able to provide warming at a controlled and variable, preset temperature.
The cooling device includes an applicator, which is the component used to apply cooling and warming to the treatment site, and the control unit which houses the system controller, power source, and other hardware. Each applicator is comprised of at least two thermoelectric coolers with an aluminum plate which is the primary skin interface for cooling and warming. The thermoelectric cooler is controlled and powered by a thermoelectric cooler controller is part of the control system. The device allows a well-controlled temperature to be applied to and maintained at the surface of the treatment area.
The Zeltiq Aesthetics Cooling Device to be used in this study has one applicator configuration. The vacuum applicator, which includes a small amount of vacuum pressure to create the massage effect. A disposable sleeve is provided for use with each of these applicators to provide an interface between the applicator and the skin. Sensors are included in the disposable sleeve to measure the temperature at the interface and to provide feedback to ensure appropriate control of the applicator temperature.
For the protection of the subject, safety features are incorporated into the device to avoid any unexpected excursions in the temperature. The device will automatically terminate the procedure if the measured temperature exceeds the minimum and maximum programmed temperature by more than one degree, i.e., 1ºC colder than the minimum programmed cooling temperature or 1ºC warmer than the maximum programmed temperature. Furthermore, the device has been tested extensively prior to being made available for use in this clinical study. Electrical safety tests to established standards (IEC-60601, UL-2601) have been performed and extensive testing has been performed to demonstrate device temperature reproducibility. Biocompatibility testing has been performed on any materials that are to contact the treatment site.
The study is intended to evaluate the large applicator of the Zeltiq Aesthetics non-invasive cooling device and to evaluate treatment of the lower abdomen to determine if non-invasive cold exposure will consistently result in a reduction of fat when used by clinicians in an environment that represents routine clinical practice.
- Conditions
- Abdominal Fat, Adipose Tissue, Abdominal
- Keywords
- Cryolipolysis, Abdominal Fat, Adipose Tissue, Fat Reduction, Non Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laser and Skin Surgery Center of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Zeltiq Aesthetics
- Investigators
- Roy G Geronemus, MD, Principal investigator, Laser & Skin Surgery Center of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318343
- Sponsor's protocol ID
- LSSC Zeltiq eZ App 8
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2011
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Subcutaneous Fat of the Abdomen Using the eZ App Large Applicator
- ClinicalTrials.gov ID
- NCT01318343
- Acronym / sponsor ID
- LSSC Zeltiq eZ App 8
- Conditions
- Abdominal Fat, Adipose Tissue, Abdominal
- Keywords
- Cryolipolysis, Abdominal Fat, Adipose Tissue, Fat Reduction, Non Invasive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laser and Skin Surgery Center of New YorkUniversity, hospital or other
- Collaborators
- Zeltiq Aesthetics
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Zeltiq Cooling Device to be used in this study (i.e, CLN1) is designed to non-invasively cool skin and subcutaneous fat. The device provides cooling at a controlled preset level (i.e., temperature) as defined by a pre-programmed treatment profile and provides continuous feedback on the temperature of the cooling plate interface with the skin. The device also is able to provide warming at a controlled and variable, preset temperature.
The cooling device includes an applicator, which is the component used to apply cooling and warming to the treatment site, and the control unit which houses the system controller, power source, and other hardware. Each applicator is comprised of at least two thermoelectric coolers with an aluminum plate which is the primary skin interface for cooling and warming. The thermoelectric cooler is controlled and powered by a thermoelectric cooler controller is part of the control system. The device allows a well-controlled temperature to be applied to and maintained at the surface of the treatment area.
The Zeltiq Aesthetics Cooling Device to be used in this study has one applicator configuration. The vacuum applicator, which includes a small amount of vacuum pressure to create the massage effect. A disposable sleeve is provided for use with each of these applicators to provide an interface between the applicator and the skin. Sensors are included in the disposable sleeve to measure the temperature at the interface and to provide feedback to ensure appropriate control of the applicator temperature.
For the protection of the subject, safety features are incorporated into the device to avoid any unexpected excursions in the temperature. The device will automatically terminate the procedure if the measured temperature exceeds the minimum and maximum programmed temperature by more than one degree, i.e., 1ºC colder than the minimum programmed cooling temperature or 1ºC warmer than the maximum programmed temperature. Furthermore, the device has been tested extensively prior to being made available for use in this clinical study. Electrical safety tests to established standards (IEC-60601, UL-2601) have been performed and extensive testing has been performed to demonstrate device temperature reproducibility. Biocompatibility testing has been performed on any materials that are to contact the treatment site.
The study is intended to evaluate the large applicator of the Zeltiq Aesthetics non-invasive cooling device and to evaluate treatment of the lower abdomen to determine if non-invasive cold exposure will consistently result in a reduction of fat when used by clinicians in an environment that represents routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Had treatment with a cooling device within the past 6 months. (This exclusion does not apply to those enrolled in Group 3).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy G Geronemus, MD principal investigator
Laser & Skin Surgery Center of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Fat and Adipose Tissue, Abdominal, run by Laser and Skin Surgery Center of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.