Pelvalon today announced the completion of enrollment of the LIBERATE clinical trial, which was designed to evaluate the 12-month durability of efficacy and safety outcomes of the Eclipse® System for female bowel control.
The LIBERATE Study, a follow-on to the previous pivotal clinical trial, LIFE, was conducted at 12 leading institutions across the U.S. The study enrolled 73 women with moderate-to-severe fecal incontinence after a successful fitting period with Eclipse, who will be followed over a 12-month treatment period. Holly E. Richter, Ph.D, M.D., director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham, served as the principal investigator of both the LIFE and LIBERATE studies.
“The LIBERATE study design is intended to validate the results from our initial pivotal study, LIFE, and evaluate outcomes from longer-term use of the Eclipse System,” said Dr. Richter. “I am very pleased that we have completed the enrollment phase of the study, and we have a robust cohort of patients now in treatment for one year. I look forward to collecting and sharing the final results.”
“Pelvalon is built on a tradition of clinical evidence, from our beginning feasibility studies at Stanford, continuing through post-market research around the U.S.,” said Miles Rosen, co-founder and CEO of Pelvalon. “Completing enrollment of LIBERATE is an important milestone, and we could not have achieved it without our many thought-leader partners at prominent institutions who share our commitment to address the needs of these patients.”
Loss of bowel control is a devastating condition, sometimes called accidental bowel leakage (ABL) or fecal incontinence (FI). Women often find themselves unable to travel, work, or engage in social activities. Typical first-line treatments include dietary changes, exercise and medications. If the issue persists, patients may need to move on to more invasive and costly treatments, such as surgery, surgical implants, or injections. The Eclipse System provides a new, non-surgical option for these women.
The Eclipse System is the first vaginal insert designed to provide immediate bowel control. Placed in the same location as a tampon or a diaphragm, the insert contains no hormones or drugs and can be removed at any time. In a clinical trial of women who used the insert for one month, Eclipse was effective in 86% of those successfully fit with the insert. The most common adverse event was discomfort, most frequently associated with the fitting process and typically resolved by just removing the insert. At the end of the study, 96% of participants successfully fit with the insert found the Eclipse to be comfortable, and 98% reported that they would recommend it to a friend.
The Eclipse System is currently available in limited U.S. centers of excellence, including centers in California, Florida, North Carolina, Alabama, New Mexico, Wisconsin, Michigan, and Washington D.C.
Headquartered in Sunnyvale, California, privately held Pelvalon aims to improve the lives of women who suffer from bowel control problems. Founded in 2010, Pelvalon’s groundbreaking technology originated from Stanford University’s Biodesign program, a collaboration between the schools of medicine and engineering. For more information, visit http://www.eclipsesystem.com.
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