Clinical Trial of "Magic Gyno" Laser Device

What this trial studies

The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: gynecology examination, vaginal health index, clinical blood test, vaginal flora examination, vaginal pH. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI) and The Short Form Health Survey (SF-36) will be used to collect feedback on changes in the participants life quality. Total up to 70 participants with pathology of pelvic organs will be involved in the study.

Conditions in scope

• Female Urogenital Diseases
• Urinary Incontinence
• Prolapse Genital
• Menopausal Syndrome
• Postmenopausal Period
• Vaginal Atrophy
• Vaginal Prolapse
• Postpartum Period

Interventions

• Laser treatment (Device) — Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 ns, the pause between pulses is 30 us. The energy of one pulse is about 1 mJ. General…
• Blood test (Diagnostic Test) — Taking blood from a vein for Wassermann reaction (WR), human immunodeficiency viruses (HIV), hepatitis B infection (HBsAg), hepatitis C infection (HCVAg) determination, glucose test (to include the participant in the study) and clinical blood analysis (to include the participant in…
• Clinical urine test (Diagnostic Test) — Urine sampling for Clinical urine test (to include the participant in the study).
• Vaginal smear (Diagnostic Test) — Vaginal smear for flora investigation (to include the participant in the study and evaluate procedure efficiency)
• Pelvic ultrasound (Diagnostic Test) — Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
• Female Sexual Function Index (Other) — Female Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Who can join

Women only · Ages 18 Years to 80 Years

Inclusion criteria

• Women from 18 years old in conditions caused by collagen deficiency in the treated area, women in premenopause and menopause;
• Participants who signed informed consent and fully informed about the purpose of the study;
• Following disorders:
• Stress urinary incontinence,
• Mixed urinary incontinence with a predominance of the stress component,
• Genitourinary menopausal syndrome,
• Dystrophic and atrophic processes in the genital area,
• Scleroatrophic changes in the urogenital region,

Exclusion criteria

• Age up to 18 years;
• Inability or unwillingness to give informed consent to participate in a trial or to fulfill the requirements of a clinical trial;
• The presence of contraindications to the use of a medical device;
• Pregnancy;
• Bleeding disorders accompanied by a violation of blood clotting;
• Use of anticoagulant medicines (post-infarction and post-stroke conditions);
• Autoimmune diseases;
• Emerging infection diseases of any etiology;

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2022-08-05
• Primary completion: 2024-01-22
• Last update posted: 2024-12-10
• First posted: 2022-07-18

Sponsor & contact

Lead sponsor: MeLSyTech, Ltd (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Mean Change from Baseline of Vaginal Health Index Score (1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
  Vaginal Health Index will be investigated by clinical examination for vagina: A. Vaginal elasticity (Characteristic=Points: None=1, Poor=2, Fair=3, Good=4, Excellent=5), B. Vaginal secretions (None=1; Sсant, thin yellow=2; Superficial, thin white=3; Moderate, thin white=4; Normal (white)=5), C. Epithelial mucous membrane (Petechiae noted before contact=1, Bleeding with light contact=2, Bleeds with scraping=3, Not friable thin epithelium=4, Normal=5), D. Vaginal hydration (None, surface…

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