Abdominal FatPhase 1NCT01976247
A Pilot Study Testing a Noninvasive Cryolipolysis Device Versus a High Intensity Focused Ultrasound Device for Fat Reduction
A Phase 1 study testing High Intensity Focused Ultrasound Device and Noninvasive Cryolipolysis Device in people with Abdominal Fat, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Fat
- What is being tested?
- High Intensity Focused Ultrasound Device and Noninvasive Cryolipolysis Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects ages 30-65 years old.
- Body mass index (BMI) between 18 and 29.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).
- Subjects are in good health.
- Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
- Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
- The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Who cannot join
- Pregnant or lactating or intends to become pregnant in the next 9 months.
- Unable to understand the protocol or to give informed consent.
- Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area.
- Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months..
- History of asthma or chronic obstructive pulmonary diseases.
- Active skin disease or skin infection in the treatment area.
Show all 9Show fewer
- Bleeding tendency or coagulopathy.
- Subjects who are allergic to lidocaine.
- Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Pilot Study Comparing the Effectiveness of a Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device for Fat Reduction: A Randomized Control Trial
The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.
Read the detailed description
At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.
- Conditions
- Abdominal Fat
- Being tested
- High Intensity Focused Ultrasound Device, Noninvasive Cryolipolysis Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused Ultrasound DeviceDevice
Also called Liposonix
Noninvasive Cryolipolysis DeviceDevice
Also called Zeltiq
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Cryolipolysis Device | Active comparator | The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart. Receives: Device: Noninvasive Cryolipolysis Device |
| High Intensity Focused Ultrasound Device | Active comparator | The LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin. Receives: Device: High Intensity Focused Ultrasound Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12
The primary outcome was a blinded rating of the treatment area (Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 12).
Measured: 1 hour at baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976247
- Sponsor's protocol ID
- STU84032
- Status last verified
- Jun 2026
- First submitted
- 15 Oct 2013
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing the Effectiveness of a Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device for Fat Reduction: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01976247
- Acronym / sponsor ID
- STU84032
- Conditions
- Abdominal Fat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 2013 (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 compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.
Detailed description
At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Cryolipolysis Device | Active comparator | Device: Noninvasive Cryolipolysis DeviceThe Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart. |
| High Intensity Focused Ultrasound Device | Active comparator | Device: High Intensity Focused Ultrasound DeviceThe LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female subjects ages 30-65 years old.
- Body mass index (BMI) between 18 and 29.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).
- Subjects are in good health.
- Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
- Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
Key exclusion criteria (9 listed)
- Pregnant or lactating or intends to become pregnant in the next 9 months.
- Unable to understand the protocol or to give informed consent.
- Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area.
- Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months..
- History of asthma or chronic obstructive pulmonary diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused Ultrasound DeviceAlso: Liposonix | Device | High Intensity Focused Ultrasound Device |
| Noninvasive Cryolipolysis DeviceAlso: Zeltiq | Device | Noninvasive Cryolipolysis Device |
Primary outcome
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12
Time frame: 1 hour at baseline and week 12
The primary outcome was a blinded rating of the treatment area (Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Related trials for Abdominal Fat
Not yet recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )
Subcutaneous Fat
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat
Not yet recruitingPhase 3
A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
Subcutaneous Fat
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat
Subcutaneous Fat
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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High Intensity Focused Ultrasound Device and Noninvasive Cryolipolysis Device in people with Abdominal Fat, run by Northwestern University 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12 (time frame: 1 hour at baseline and week 12). It is what the study was designed to measure, not a finding.
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 1 Jul 2026.