Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT05968495
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Sponsor:
Apyx Medical
Organization:
Study Overview
Official Title:
Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Status:
COMPLETED
Status Verified Date:
2025-01
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:
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. All adverse events and expected treatment effects will be documented.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, \& D365.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, \& D365.
Detailed Description:
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Demographic information, medical history, and procedure details will be documented. Pre- and post-procedure care are per investigator standard of care and documented. Video may be taken during the procedure.
Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area prior to study treatment.
Post-procedure care will be as per investigator standard of care and documented. All adverse events and expected treatment effects will be documented.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, \& D365.
Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area prior to study treatment.
Post-procedure care will be as per investigator standard of care and documented. All adverse events and expected treatment effects will be documented.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, \& D365.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: