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Trial record 2 of 294 for:    fecal | Recruiting | Exclude Unknown | United States

A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women (LIBERATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Pelvalon, Inc.
Sponsor:
Information provided by (Responsible Party):
Pelvalon, Inc.
ClinicalTrials.gov Identifier:
NCT02428595
First received: April 18, 2015
Last updated: September 10, 2016
Last verified: September 2016
  Purpose
Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.

Condition Intervention
Fecal Incontinence
Device: Eclipse™ System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

Resource links provided by NLM:


Further study details as provided by Pelvalon, Inc.:

Primary Outcome Measures:
  • Proportion of treatment Responders in the Intent to Treat (ITT) cohort [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    % reduction in the average number of FI episodes per week


Secondary Outcome Measures:
  • Proportion of treatment responders in the Per Protocol (PP) population [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    % reduction in the average number of FI episodes per week

  • Change in mean scores on subject-reported outcomes related to symptom severity [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    St. Mark's (Vaizey) Incontinence Severity Score

  • Patient Global Impression of Improvement (PGI-I) scores [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Change in mean scores on subject-reported outcomes related to QoL [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Fecal Incontinence QoL (FIQoL)


Other Outcome Measures:
  • Safety Endpoint [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
    The number of device-related adverse events, and device-related serious adverse events


Estimated Enrollment: 150
Study Start Date: May 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Eclipse™ System
Device: Eclipse™ System
The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.
Other Name: Vaginal Bowel Control (VBC) Therapy

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Abbreviated Inclusion Criteria:

  • History of FI for at least 6 months
  • Subject willing and able to give written informed consent to participate in the study
  • Subject can read, write and communicate fluently in English
  • Subject willing and able to comply with visit schedule
  • Subject is able to physically manage the insertion and removal of the Insert

Abbreviated Exclusion Criteria:

  • Vaginal childbirth within the last 18 months
  • Currently pregnant or planning pregnancy during the study period
  • Acute infections or genito-urinary injuries that would impact comfortable device use
  • Current treatment for FI other than medical management
  • Removal or diversion of any portion of the bowel
  • Recent urogenital or colorectal surgeries
  • Chronic abdominal pain in absence of diarrhea
  • Chronic (>6 mos) rectal, anal or pelvic pain
  • Chronic watery diarrhea, unmanageable by drugs or diet
  • Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis
  • Rectal prolapse (mucosal or full thickness)
  • Grade III or IV hemorrhoids
  • Pelvic organ prolapse beyond the plane of the hymen
  • Concurrent use of intra-vaginal pessary or other device
  • Anal or pelvic malignancy within last 5 years
  • History of pelvic irradiation for cancer
  • Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02428595

Contacts
Contact: Cindy Jahans, BSc 650-276-0130 Cindy@pelvalon.com
Contact: Alison Moe, BSc 650-276-0130 Alison@pelvalon.com

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alice Howell, BSN, CCRC    205-975-8592    ahowell@uabmc.edu   
Contact: Robin Willingham, BSN    205-934-3904    rwillingham@uabmc.edu   
Principal Investigator: Holly Richter, MD         
United States, Massachusetts
Massachusetts General Hospital (MGH) Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Eileen Armes    505-967-8428    hsc-urogyn-research@salud.unm.edu   
Contact: Karen Box    505-967-8428    hsc-urogyn-research@salud.unm.edu   
Principal Investigator: Gena Dunivan, MD         
United States, North Carolina
University of North Carolina Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Betty Rupp, MPH    919-843-8114    brupp@med.unc.edu   
Principal Investigator: Jennifer Wu, MD         
United States, Ohio
Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Marsha Zartman, BSN, CCRC    513-463-2509    marsha.zartman@thechristhospital.com   
Contact: Sharon Lamping, MA, CRC    513-585-2166    sharon.lamping@thechristhospital.com   
Principal Investigator: Ian Paquette, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Trynisha Cheadle, RN    405-271-8001 ext 46205    trynisha-cheadle@ouhsc.edu   
Principal Investigator: Dena O'Leary, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lorraine Flick    215-615-6569    lorraine.flick@uphs.upenn.edu   
Contact: Michelle Kinglee    215-615-6569    michelle.kinglee@uphs.upenn.edu   
Principal Investigator: Uduok Andy, MD         
United States, Rhode Island
Brown University (WIHRI) Recruiting
Providence, Rhode Island, United States, 02903
Contact: Nancy Toth, Coordinator    401-274-1122 ext 48226    NToth@wihri.org   
Contact: Ann Meers, RN    401-274-1122 ext 48228    ameers@wihri.org   
Principal Investigator: Charles Rardin, MD         
United States, Texas
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Konny Chan Fong    713-363-7592    fkchanfong@houstonmethodist.org   
Contact: Jaya Kamath    713-441-6616    jskamath@houstonmethodist.org   
Principal Investigator: Muir Tristi, MD         
Sub-Investigator: Danielle Antosh, MD         
United States, Washington
Providence Sacred Heart Recruiting
Spokane, Washington, United States, 99204
Contact: Joan Milton, MS, CCRC    509-474-4323    joan.e.milton@providence.org   
Principal Investigator: Shane McNevin, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Robin Wasielewski, CCRC    608-417-4230    rwasielewsk2@wisc.edu   
Principal Investigator: Heidi Brown, MD         
Sponsors and Collaborators
Pelvalon, Inc.
Investigators
Principal Investigator: Holly Richter, PhD, MD University of Alabama at Birmingham
  More Information

Additional Information:
Publications:
Responsible Party: Pelvalon, Inc.
ClinicalTrials.gov Identifier: NCT02428595     History of Changes
Other Study ID Numbers: CA005 
Study First Received: April 18, 2015
Last Updated: September 10, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 29, 2016