Urinary Incontinence Clinical Trial
Official title:
An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, "G" spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy. The main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation. The MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid. The MMG-23-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device. ;
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