Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:45 AM
Study NCT ID:
NCT04511260
Status:
UNKNOWN
Last Update Posted:
2020-12-08
First Post:
2020-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
Sponsor:
Lumenis Be Ltd.
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
Detailed Description:
The treatment will include: A treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece (optional).
This is a single center, prospective, open label, single arm study. Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment.
This is a single center, prospective, open label, single arm study. Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment.
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?: