LIBERATE-A Clinical Evaluation of the Eclipse System; a Vagi Bowel Control nal(VBC) Therapy for Fecal Incontinence in Women
Fecal Incontinence (FI), also known as Accidental Bowel Leakage (ABL), meaning you do not always have control over your bowels. Your study doctor has determined that your loss of bowel control might be helped by the LIBERATE study device, which is called the Eclipse System. Contact: Lorraine Flick/Michelle Kinglee/Akudo Ejeluno Phone: 215-615-6569
The purpose of this study is to evaluate the long term use of the Eclipse System to treat ABL in adult women. Your study participation may last for approximately 15 months, with up to 10 study visits. The first few visits may take from 1 to 1.5 hours each. The later visits may take a half hour to 1 hour each. 150 subjects will be enrolled at approximately 15 sites into the 12 month Treatment Period. The information obtained in this study will be used to help understand the effectiveness and safety of the Eclipse Insert (described below) while wearing the device for up to 12 months.
The Eclipse System (manufactured by Pelvalon Inc., Sunnyvale CA) is intended to help you regain control over your bowel movements. The system includes a vaginal insert and a separate, hand-held pump. The Eclipse Insert is placed into your vagina, resting in the same place as a tampon. The Insert is composed of a ring and an inflatable balloon. When you inflate the balloon using the handheld pump, it will help to control your rectum, preventing stool from passing when you’re not ready for it. When you’re ready to have a bowel movement, the balloon is deflated. Once you have finished your bowel movement, you will inflate the balloon again for bowel control. The Eclipse System also includes a Trial Insert for wearing at home during an evaluation period, and a Sizing Kit, which is only used by your physician during your Fitting Visit.