Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

NACompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

June 15, 2018

Primary Completion Date

April 8, 2021

Study Completion Date

April 8, 2021

Conditions
Vaginal Atrophy
Interventions
DEVICE

IntraGen RF

IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally.

DEVICE

DiVA

DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner.

DEVICE

Placebo (DIVA/IntraGen combined)

"(DIVA/IntraGen combined) IntraGen RF: IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally.~DiVA: DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner."

Trial Locations (1)

75390

University of Texas Southwestern Medical Center, Dallas

All Listed Sponsors
collaborator

American Society for Aesthetic Plastic Surgery

OTHER

lead

University of Texas Southwestern Medical Center

OTHER

NCT03316950 - Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation | Biotech Hunter | Biotech Hunter