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

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ClinicalTrials.gov Identifier: NCT02428595
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pelvalon, Inc.

Tracking Information
First Submitted Date  ICMJE April 18, 2015
First Posted Date  ICMJE April 29, 2015
Results First Submitted Date  ICMJE May 9, 2019
Results First Posted Date  ICMJE September 24, 2019
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE May 15, 2015
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
Count of Treatment Responders in the Intent to Treat (ITT) Cohort [ Time Frame: 3 months ]
Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
  • Count of Treatment Responders in the Per Protocol (PP) Population [ Time Frame: 3, 6 and 12 months ]
    Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.
  • Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline [ Time Frame: 12 months ]
    Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score. St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome.
  • Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline [ Time Frame: 12 months ]
    Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score. The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points. The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0. The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life. An increase in score as compared to Baseline is therefore a better outcome.
  • Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores [ Time Frame: 3, 6, 9 and 12 months ]
    The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline. The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome. Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 30, 2019)
Safety Endpoint - Number of Device Related Adverse Events [ Time Frame: 3, 6, 9 and 12 months ]
The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely). Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Official Title  ICMJE A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fecal Incontinence
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Treatment
Eclipse™ System
Intervention: Device: Eclipse™ System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2019)
137
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 18, 2018
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Abbreviated Inclusion Criteria:

  • History of Fecal Incontinence (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 Fecal Incontinence 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02428595
Other Study ID Numbers  ICMJE CA005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pelvalon, Inc.
Study Sponsor  ICMJE Pelvalon, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Holly Richter, PhD, MD University of Alabama at Birmingham
PRS Account Pelvalon, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP