Formal Study NameA Clinical Evaluation of the Eclipse System, A Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women.
Additional Principal InvestigatorCharles Rardin
The LIBERATE study involves the Eclipse™ System, which uses a vaginal insert to control passage of stool in the rectum. The insert, which is non-surgical and does not contain drugs or hormones, rests in the same area as a tampon would and can be easily removed and replaced at any time by the patient. Participation may last approximately 15 months.
Ann Meers, Research Nurse: (401) 274-1122, ext. 48228
Erika Spearin, Research Assistant: (401) 274-1122, ext. 48226
You may be eligible to participate in this study if you:
- Are a woman with a history of accidental bowel leakage for at least six months.
- Are 19 years of age or older.
- Have not given birth in the past 18 months and do not plan to become pregnant during your study participation.
You will receive financial compensation of up to $675 for completed visits, calls, questionnaires, and diaries.
More Information/FAQWhat will I be asked to do?
If you are eligible, you will be taught how to use and maintain the ECLIPSE insert. Your study participation will last approximately 15 months and will include in-person visits, telephone calls, completion of symptom questionnaires, and bowel diaries.
What happens to the information collected about me?
All research information is protected and treated confidentially. Your identity will not be reported on study forms or released to anyone outside the hospital.
Can I drop out of the study once I have begun?
Participation in the study is completely voluntary, and you may remove yourself from the study at any point. If you decide to drop out of the study, you may still choose to receive medical care from our healthcare providers.
What will the study cost me?
All study-related treatments and visits are provided at no cost. Any medical care outside of the study would be charged to you or to your insurance in the usual way.
Women & Infants