Summary:
LIBERATE: The Eclipse™ System for Accidental Bowel Leakage
Are you a woman experiencing loss of bowel control? The LIBERATE Study may be right for you!
LIBERATE is a research study for women experiencing bowel control problems. Accidental Bowel Leakage (ABL) or Fecal Incontinence (FI) is sometimes associated with an intense urge to rush to the bathroom. It can also happen with no warning. This condition particularly affects women who have experienced obstetric trauma from childbirth, or other nerve or muscle damage in the pelvic region. Many women suffer in silence, fearing accidents and restricting their daily activities, not realizing that treatments exist which may help restore bowel control.
The study is evaluating the investigational Eclipse System, designed to provide immediate bowel control. The Eclipse System includes a vaginal insert and a hand-held pump for inflating and deflating a balloon on the insert. The insert is placed in the vagina, resting in the same place as a diaphragm or tampon. The insert is non-surgical and does not contain drugs or hormones. The Eclipse is designed to control the rectum from within the vagina in order to prevent accidental stool passage when the balloon is inflated. It may be removed at any time.
LIBERATE study participation may last approximately 15 months.
Qualified Participants Must:
• Be female
•
Be at least 19 years of age
•
Have a history of accidental bowel leakage for at least 6 months
Qualified Participants May Receive:
Some modest compensation for each visit completed, and physical exams and investigational devices are provided to study participants at no cost.