Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 5:04 PM
Study NCT ID:
NCT05199506
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite
Sponsor:
Soliton
Organization:
Study Overview
Official Title:
A Single Center Prospective Study to Evaluate the Safety and Effectiveness of the Soliton® Rapid Acoustic Pulse (RAP)™Device for the Improvement in the Appearance of Cellulite.
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this single site clinical study is to evaluate the safety and effectiveness of the Soliton Rapid Acoustic Pulse (RAP) device for the improvement of cellulite comparing two different RAP treatment doses.
Detailed Description:
This is a non-significant risk, single-center, prospective trial for safety, and efficacy using Soliton's RAP device for the improvement in the appearance of cellulite performed at 1 (one) clinical research site in the United States.
Approximately 15 healthy female participants between the age of 18-55 inclusive will be enrolled in this study.
Participants who sign the informed consent form and meet all the eligible criteria will be enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on each of the participants buttocks and legs. The participant's right buttock and leg will receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.
Total study duration is anticipated to be at or less than 55 weeks from the first participant visit to the last participant observation visit. A total of 3 visits, plus two optional visits are planned for this study as listed below:
* Visit 1: Baseline/Screening (-30 Days to Day 0)
* Visit 2: Treatment (Day 0)
* Visit 3: 12-week Follow-Up Visit (+/- 14 Days)
* Visit 4: 26-week Follow-Up Visit (+/- 14 Days) (Optional)
* Visit 5: 52 Week Follow-Up Visit (+/- 14 Days) (Optional)
Approximately 15 healthy female participants between the age of 18-55 inclusive will be enrolled in this study.
Participants who sign the informed consent form and meet all the eligible criteria will be enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on each of the participants buttocks and legs. The participant's right buttock and leg will receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.
Total study duration is anticipated to be at or less than 55 weeks from the first participant visit to the last participant observation visit. A total of 3 visits, plus two optional visits are planned for this study as listed below:
* Visit 1: Baseline/Screening (-30 Days to Day 0)
* Visit 2: Treatment (Day 0)
* Visit 3: 12-week Follow-Up Visit (+/- 14 Days)
* Visit 4: 26-week Follow-Up Visit (+/- 14 Days) (Optional)
* Visit 5: 52 Week Follow-Up Visit (+/- 14 Days) (Optional)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: