An evidence-based approach to developing
a new bowel control treatment

effective treatment
effective treatment

86% of patients who completed the LIFE study achieved treatment success1

highly recommended
highly recommended

98% reported they would recommend Eclipse to a friend1

We believe that medical innovation is built on a foundation of clinical research and evidence.

Our clinical program has demonstrated that the Eclipse System is:

immediately effective

The Eclipse System is clinically proven to provide a significant reduction in ABL episodes in women successfully fit with the insert.1

Low-risk

A low-risk treatment with no serious adverse events associated with the device reported in a pivotal study.1

proven satisfaction

Women who completed a clinical study reported improvement on all tested Quality of Life measures, including comfort and device satisfaction.1

The LIFE Study

The Eclipse System was studied in a multi-center clinical trial in the United States, called LIFE. The LIFE Study demonstrated the effectiveness and safety of the Eclipse System. One hundred and ten women who were eligible to be fitted with the Eclipse Insert enrolled in the study. Sixty-one women achieved a successful fit and went on to a one-month evaluation period.

The LIFE study was led by Holly E. Richter, Ph.D., M.D., Director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham, and past President of the Society for Gynecological Surgeons (SGS). Primary results of this study were published in Obstetrics & Gynecology, and an additional analysis of the impact of Eclipse on bowel symptoms associated with ABL was published in Diseases of the Colon and Rectum.

Key Statistics from the LIFE Study

Zero serious device-related adverse events were reported in the study. All device-related adverse events were rated as mild (78%) or moderate (22%). The majority of adverse events were experienced during the fitting period. There were substantially fewer occurrences once subjects were successfully fit with the device and entered treatment. The most common adverse event was pelvic cramping and discomfort, and other observed events included pelvic pain, vaginal spotting and urinary incontinence. 110 women participated in the fitting process, and 61 of those women entered the study; those who discontinued did so mostly for fit-related reasons. Those who were fit experienced a reduction from an average baseline of 6 episodes per week to 1 episode per week after 1 month of wear.

Other Studies

Feasibility Studies

Previous studies included over 100 patients to establish the safety and comfort of earlier generations of the Eclipse System. These studies were completed under the leadership of Eric Sokol, M.D., Associate Professor of Obstetrics and Gynecology and, by courtesy, of Urology at the Stanford University Medical Center, and Michelle Takase-Sanchez, M.D., of the Division of Urogynecology & Female Pelvic Medicine at Ventura County Obstetric and Gynecologic Medical Group. Results in these preliminary populations demonstrated similar success rates as those later shown in the pivotal LIFE study.

Current Clinical Research

Pelvalon is committed to an on-going research program to continue to characterize this groundbreaking new therapy. If you would like to learn more or are interested in participating, please visit clinicaltrials.gov.

Publications

Peer-Reviewed Literature

SAFETY INFORMATION
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