Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis.
Pedro AciénFrancisco Jose Nohales-AlfonsoMaria Luisa Sánchez FerrerMiguel Sánchez LozanoVictoria Navarro-LilloMaria Isabel AciénPublished in: BMC women's health (2019)
This clinical study was approved by the Ethical Clinical Investigation Committee of San Juan University Hospital on September 27, 2016, to be conducted in the participating centres; it was authorized by the Spanish Agency of Medicines and Health Products (AEMPS) on April 24, 2017 (exp. no. 585/16/EC), to be carried out in that hospitals.