Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Wome… (NCT05058313) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy
France25 participantsStarted 2022-03-29
Plain-language summary
Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Management of urogenital atrophy includes lifestyle modification, nonhormonal treatments (vaginal lubricants or moisturizers, laser treatments), as well as hormonal treatments. The disadvantages of the non-surgical methods are average results, discontinuation, and frequent contraindications to hormonal treatments.This has led to a strong interest in the development of non-invasive or minimally invasive methods that are easy to implement, effective and durable.
Photobiomodulation therapy (PBMT) has been proposed as an alternative for the treatment of genitourinary menopausal syndrome (GMS) and stress urinary incontinence. PBMT devices exert their effect via non-thermal mechanisms. PBMT stimulates collagen and elastin synthesis in the vaginal tissue, to support the urethrovaginal sphincter and urethra, and to promote vasodilation in the vaginal and urethral submucosa. PHYSIOQUANTA has developed a vaginal probe coupled with its innovative MILTA™ process synergistically combining NPCL (Nano-Pulsed Cold Laser) laser emitters, infrared diodes and RGB (Red Green Blue) diodes, operating in a magnetic tunnel. The MILTA acts deeper than LEDs, due to the diffusion of photons in soft tissues.
In this study, the study investigators aimed to evaluate the safety and performance of the MILTA™ GYNECO vaginal probe in a pilot study of first use in women. This clinical study on the MILTA vaginal probe is expected to result in its CE marking Class IIb DM.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with pelvic discomfort/pain (pain, dryness, irritation, etc.) due to vaginal atrophy that has failed all non-invasive therapies for over 3 months.
* Postmenopausal patient recruited during a consultation in the Gynecology department of the University Hospital of Nîmes or at the KARIS Medical Center in Perpignan and having undergone a complete clinical examination allowing any physical and / or psychological cause to be eliminated.
* Patient who has given her free and informed consent.
* Patient affiliated or beneficiary of a health insurance plan.
Exclusion Criteria:
* Patient not available for the 6-week follow-up.
* Patient presenting with pelvic pain of physical and / or psychological origin.
* Patients undergoing initial treatment for cancer and/or who have completed their treatments within the last year
* Patient with immunosuppression.
* Allergy to the material of the probe protection used (latex for example).
* Pregnancy.
* Implantable device active in the heart such as a defibrillator or a pacemaker, neuromodulation stimulator, electrodes implanted for the treatment of Parkinson's disease.
* Epilepsy, photophobia, recent intake of photosensitizing drugs or cosmetics (in the last 6 months), history of porphyria.
* Patient participating in category 1 interventional study.
* Patient in an exclusion period determined by another study.
* Patient under legal protection, under guardianship or under curatorship.
* Patient for whom it is…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Timeframe: Day 1
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Timeframe: Week 1
3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Timeframe: Week 2
4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Timeframe: Week 3
5
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Timeframe: Week 4
6
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe