Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
El. En. SpA
With
The Christ Hospital
Stanford University
The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment.
Age
45–60
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
Exhibiting VVA symptoms
Prolapse staged \< II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
Have not had procedures in the anatomical area through 6 months prior to treatment
Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
You may not be if
• Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
* Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
* Any serious disease, or chronic condition, that could interfere with the study compliance
* Previously undergone reconstructive pelvic surgery
* Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
* Taking medications that are photosensitive
* A history of keloid formation
Clareo Health | Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
