Body Weight ChangesNCT04568187
Cryolipolysis Induced Gluteal Fat Change
A study testing zeltiq in people with Body Weight Changes, run by Wonik Trade Company, Korea at 1 site in South Korea.
Trial summary
There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine. Cryolipolysis was found to be safe for 12 week clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- zeltiq
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2010to 31 Aug 2010
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pre-menopausal healthy women
- subjects with body mass index ≥ 18
- subjects with visible fat on both thigh
- subjects to understand and agree to this study protocol
Who cannot join
- subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia
- subjects with pregnancy or lactation within 6 months or next 3 months
- subjects with any laboratory, or metabolic abnormalities
- uncooperative subjects to comply with the study protocol
- women taking any medication/ over the counter/herbal supplements to regulate weight or fat mass over 6 months
- subjects with menstrual irregularities
Show all 9Show fewer
- subjects to change over 10% of the former weight within the past 6 months - any procedure such as liposuction, or another surgical procedure or mesotherapy to reduce fat within 6 months
- subjects with any dermatologic abnormalities on the target areas (thigh)
- subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bariatric clinic/Family medicine, Hong-Ik General Hospital
Seoul
About this study
Official title: Clinical Efficacy of Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine.
Cryolipolysis was found to be safe for 12 week clinical trial.
Read the detailed description
this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis.
Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.
- Conditions
- Body Weight Changes
- Being tested
- zeltiq, placebo
- Keywords
- fat, cryolipolysis, Women, femoral fat
- Medical subject headings
- Body Weight Changes, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zeltiqDevice
Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
placeboDevice
radiofrequency with 3000 Hz
| Study group | Role | What they receive |
|---|---|---|
| cryolipolysis machine on Left inner thigh | Active comparator | Zeltiq machine as intervention procedure was carried out on left inner thigh (treated side) for 1 hour through cool sculpting procedure with CIF (Cooling Intensity Factor: -73 mW/cm2). Receives: Device: zeltiq |
| radiofrequency on right thigh | Sham comparator | The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once. Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of girths in both thighs
Comparison of circumferences of both thighs
Measured: 4 weeks
The change of fat amounts in both thighs
Comparison of cross-sectional areas in both thighs
Measured: 4 weeks
Secondary outcomes (2)
The change of girths in both thighs
Comparison of circumferences of both thighs
Measured: 12 weeks
The change of fat amounts in both thighs
Comparison of cross-sectional areas in both thighs
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 May 2010
- Primary completion31 Aug 2010
- Study completion31 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- the sequential split-body trials
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonik Trade Company, Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu R Lee, MD, PhD, Principal investigator, Hongik General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568187
- Sponsor's protocol ID
- 01177787
- Status last verified
- Dec 2020
- First submitted
- 19 May 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
- ClinicalTrials.gov ID
- NCT04568187
- Acronym / sponsor ID
- 01177787
- Conditions
- Body Weight Changes
- Keywords
- fat, cryolipolysis, Women, femoral fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wonik Trade Company, KoreaIndustry (pharma, biotech, devices)
- Study start
- 1 May 2010 (actual)
- Primary completion
- 31 Aug 2010 (actual)
- Study completion
- 31 Aug 2010 (actual)
- First posted
- 29 Sep 2020 (actual)
- 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.
There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine.
Cryolipolysis was found to be safe for 12 week clinical trial.
Detailed description
this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis.
Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the sequential split-body trials
| Arm | Type | Receives |
|---|---|---|
| cryolipolysis machine on Left inner thigh | Active comparator | Device: zeltiqZeltiq machine as intervention procedure was carried out on left inner thigh (treated side) for 1 hour through cool sculpting procedure with CIF (Cooling Intensity Factor: -73 mW/cm2). |
| radiofrequency on right thigh | Sham comparator | Device: placeboThe radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pre-menopausal healthy women
- subjects with body mass index ≥ 18
- subjects with visible fat on both thigh
- subjects to understand and agree to this study protocol
Key exclusion criteria (9 listed)
- subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia
- subjects with pregnancy or lactation within 6 months or next 3 months
- subjects with any laboratory, or metabolic abnormalities
- uncooperative subjects to comply with the study protocol
- women taking any medication/ over the counter/herbal supplements to regulate weight or fat mass over 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zeltiqZeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010 | Device | cryolipolysis machine on Left inner thigh |
| placeboradiofrequency with 3000 Hz | Device | radiofrequency on right thigh |
Primary outcome
The change of girths in both thighs
Time frame: 4 weeks
Comparison of circumferences of both thighs
The change of fat amounts in both thighs
Time frame: 4 weeks
Comparison of cross-sectional areas in both thighs
2 secondary outcomes
The change of girths in both thighs
Time frame: 12 weeks
The change of fat amounts in both thighs
Time frame: 12 weeks
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 7 Dec 2020.
- clinical efficacy of fat reduction on the thigh of Korean women through cryolipolysisLink provided by the sponsor.
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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.
Kyu R Lee, MD, PhD principal investigator
Hongik General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zeltiq in people with Body Weight Changes, run by Wonik Trade Company, Korea at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 7 Dec 2020. 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 South Korea. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
The change of girths in both thighs (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 7 Dec 2020.