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NCT05463081
Clinical Trial of "Magic Gyno" Laser Device
NA trial testing Laser treatment in Female Urogenital Diseases in 70 participants. Completed in 22 January 2024.
22 January 2024
Quick facts
| Lead sponsor | MeLSyTech, Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 70 |
| Start date | 5 August 2022 |
| Primary completion | 22 January 2024 |
| Estimated completion | 22 January 2024 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Laser treatment
- Blood test — full drug profile →
- Clinical urine test
- Vaginal smear
- Pelvic ultrasound
- Female Sexual Function Index
- International Consultation on Incontinence Questionnaire - Short Form
- The Short Form Health Survey
- Vaginal Health Index
- Vital signs determination
- pH of vagina determination
- Physical parameters determination
Conditions studied
- Female Urogenital Diseases — all drugs for Female Urogenital Diseases →
- Urinary Incontinence — all drugs for Urinary Incontinence →
- Prolapse Genital — all drugs for Prolapse Genital →
- Menopausal Syndrome — all drugs for Menopausal Syndrome →
Sponsor
MeLSyTech, Ltd — full company profile →
Who can join
Adults 18 to 80, female only, with Female Urogenital Diseases or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms, by 35 participants in each. The time intervals between tests will be the same for both groups. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the condition before treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05463081
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Laser treatment
Trials testing the same drug.
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- NCT04249024 — Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery · NA · completed
- NCT03383120 — Diode Laser for Treatment of Peri-implantitis · NA · completed
- NCT02696408 — Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis Du · Phase 3 · completed
Other recruiting trials for Female Urogenital Diseases
Currently open trials in the same condition.
- NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting
- NCT06237920 — Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab · Phase 2 · recruiting
- NCT05000957 — Pelvic Organs Prolapse Treatment Using Neodymium Laser · NA · active not recruiting
Other MeLSyTech, Ltd trials
Trials by the same sponsor.
- NCT05335317 — Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser · NA · recruiting
- NCT05000957 — Pelvic Organs Prolapse Treatment Using Neodymium Laser · NA · active not recruiting
- NCT04735549 — Vulvovaginal Atrophy Correction Using Neodymium Laser · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05463081 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MeLSyTech, Ltd
- Last refreshed: 10 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05463081.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing