A national multicenter clinical trial of the next generation Eclipse System for fecal incontinence in women has enrolled its first patient, the manufacturer announced.
The Eclipse System (Pelvalon) is a vaginal insert with an inflatable balloon designed to provide bowel control by occluding the rectum and preventing unwanted stool passage, according to a press release. A previous version of the Eclipse System received FDA approval in February following positive results from the LIFE study, but has not yet been commercially released. The current version being studied in the LIBERATE trial is limited to investigational use only.
“Many women of all ages suffer in silence, fearing accidents and restricting their daily activities, because of the embarrassing stigma around the condition and the lack of treatment options,” Holly Richter, MD, PhD, director of the division of urogynecology and pelvic reconstructive surgery at University of Alabama Birmingham Hospital, said in a press release. “The Eclipse System is the first of its kind, and presents new opportunities for treating women with bowel-control problems. We anticipate this new technology will encourage patients and physicians to start a new dialogue about bowel control.”
Participants in the LIBERATE study will be followed for 12 months, providing longer term data than the 3-month LIFE study, the release said. UAB Hospital is one of 15 U.S. centers participating in the trial, and 150 patients are expected to be enrolled.
“Bowel-control problems are debilitating to a woman’s emotional health and quality of life,” Richter said. “Given the limited current treatment options, we are excited to be participating in this important clinical study.”
Disclosures: Richter reports she has been a consultant for Pelvalon, and also reports relationships with Kimberly Clark and UpToDate.