CompletedNot Applicable

Outer Thigh Study With Varied Treatment Parameters

United States40 participantsStarted 2014-02-04

Plain-language summary

The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female subjects \> 18 years of age and \< 65 years of age.
✓. Subject has clearly visible fat on the intended treatment area (lateral thighs), which in the investigator's opinion, may benefit from the treatment.
✓. Subject has not had weight change exceeding 10 pounds in the preceding month.
✓. Subject with body mass index (BMI) up to 30. 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, 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 2 months.
✕. Subject has significant asymmetry between the lateral thighs.
✕. 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.

What they're measuring

Safety of the Zeltiq Device

Timeframe: Time of enrollment though16 weeks post-treatment (approximately 5 months)

Safety of the Zeltiq Device

Timeframe: From enrollment through 16 week follow-up (approximately 5 months)

Percentage of Pre-treatment Images Correctly Identified.

Timeframe: Baseline and 16 weeks post-treatment

Trial details

NCT IDNCT02081209

SponsorZeltiq Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10-21

Results submitted2020-08-30

View on ClinicalTrials.gov More Body Fat Disorder trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female subjects \> 18 years of age and \< 65 years of age.
✓. Subject has clearly visible fat on the intended treatment area (lateral thighs), which in the investigator's opinion, may benefit from the treatment.
✓. Subject has not had weight change exceeding 10 pounds in the preceding month.
✓. Subject with body mass index (BMI) up to 30. 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, 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 2 months.
✕. Subject has significant asymmetry between the lateral thighs.
✕. 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.

What they're measuring

Safety of the Zeltiq Device

Timeframe: Time of enrollment though16 weeks post-treatment (approximately 5 months)

Safety of the Zeltiq Device

Timeframe: From enrollment through 16 week follow-up (approximately 5 months)

Percentage of Pre-treatment Images Correctly Identified.

Timeframe: Baseline and 16 weeks post-treatment