Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

Soliton

Status

Completed

Conditions

Cellulite

Treatments

Device: Soliton's Rapid Acoustic Pulse (RAP)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04065711

2019-002

Details and patient eligibility

About

To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.

Full description

Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.

Enrollment

67 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female ages 18-50 years
Seeking treatment of cellulite in the thigh and/or buttock areas
Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
Stable weight nominally +/- 5% for at least the past 6 months.
Body Mass Index (B.M.I.) is ≤ 30
Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment.
Participant is willing to participate in study and adhere to follow-up schedule
Participant is able to read and comprehend English
Participant has completed the Informed Consent Form

Exclusion criteria

Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
Participant is pregnant or planning to become pregnant during the duration of the study.
Has atrophic scars, or has a history of atrophic scars or keloids.
Tattoo or former tattoo at or near treatment area.
Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.).
Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.).
History of coagulopathy(ies) and/or on anticoagulant medication.
Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
Current smoker.
Any surgical procedure in the prior 3 months, or planned during the duration of the study.