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Coolsculpting With Cooltone Verses Coolsculpting Alone for the Banana Roll Area

Sponsored by Goldman, Butterwick, Fitzpatrick and Groff

About this trial

Last updated 3 years ago

Study ID

Coolsculpt-Cooltone-2022

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
22 to 65 Years
Female
Female

Trial Timing

Ended 3 years ago

What is this trial about?

to evaluate the benefit and efficacy of CoolSculpting Elite study treatments versus CoolSculpting Elite study treatments followed by a series CoolTone for underneath the buttocks (also known as the banana roll).

What are the Participation Requirements?

Inclusion Criteria:

- Inclusion Criteria

1. Female ≥ 22 years and ≤65 years of age.

2. Subject has not had weight change exceeding 5% of body weight in the preceding
month.

3. Subject agrees to maintain body weight within 5% during the study by not making
any changes in diet or exercise routine.

4. Subject has a BMI ≤ 30 as determined at screening.

5. Subject agrees to have photographs taken of the treatment area(s) during the
scheduled time periods.

6. Subject agrees to refrain from any new or change in gluteal muscle training
exercises of the treatment area during the course of the study.

7. Subject agrees to avoid sun tanning or spray tanning during the course of the
study. Subject has read and signed the study written informed consent form

Exclusion Criteria:

- Exclusion Criteria

1. Male Subjects

2. Subject has had a recent surgical procedure(s) in the area of intended treatment
and muscle contractions may disrupt the healing process.

3. A subject with any uncontrolled systemic disease. A potential subject in whom
therapy for a systemic disease is not yet stabilized will not be considered for
entry into the study.

4. A subject with a significant history or current evidence of a medical,
psychological or other disorder that, in the investigator's opinion, would
preclude enrollment into the study.

5. Subject has had an invasive fat reduction procedure (e.g., liposuction,
mesotherapy) non-invasive fat reduction or skin tightening procedures , or
cellulite treatment in the area of intended treatment

6. Subjects who tanned or spray tanned in the treatment area within the past 4 weeks

7. A subject with history of or the presence of any skin condition/disease in the
treatment area that might interfere with the diagnosis or evaluation of study
parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at
the discretion of the investigator.

8. 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

9. Subject hashad an intrauterine contraceptive device inserted or removed within
the past month.

10. A subject with an active bacterial, fungal, or viral infection in the treatment
area.

11. Subject has a bleeding disorder

12. Subject has a blood disorder such as cryoglobulinemia, cold agglutinin disease
and paroxysmal cold hemoglobinuria.

13. Known sensitivity to cold such as cold urticaria, Raynaud's disease, pernio or
Chilblains. Or patients with any impaired sensation in treated area

14. A subject with scarring or tattoos in the treatment area that might interfere
with the diagnosis or study evaluations at the discretion of the investigator.

15. Subject is taking or has taken diet pills or supplements within the past month.

16. Subject has a metal implant or active implanted device such as a cardiac
pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or
drug delivery system.

17. Subject has pulmonary insufficiency.

18. Subject has a cardiac disorder.

19. Subject has a malignant tumor.

20. Subject has been diagnosed with a seizure disorder such as epilepsy.

21. Subject currently has a fever.

22. Subject is diagnosed with Grave's disease.

23. Subject is pregnant or intending to become pregnant during the study period (in
the next 9 months).

24. Subject is lactating or has been lactating in the past 6 months.

25. Subject is unable or unwilling to comply with the study requirements.

26. Subject is currently enrolled in a clinical study of any other investigational
drug or device.

27. Current participation or participation within 30 days prior to the start of this
study in a drug or other investigational research study.

28. 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

Locations

Location

Status

Recruiting
Recruiting