search
Back to results

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

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eclipse™ System
Sponsored by
Pelvalon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Massachusetts General Hospital (MGH)
  • University of New Mexico
  • University of North Carolina
  • Christ Hospital
  • University of Oklahoma
  • University of Pennsylvania
  • Brown University (WIHRI)
  • Houston Methodist
  • Providence Sacred Heart
  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Eclipse™ System

Outcomes

Primary Outcome Measures

Count of Treatment Responders in the Intent to Treat (ITT) Cohort
Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.

Secondary Outcome Measures

Count of Treatment Responders in the Per Protocol (PP) Population
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
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
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
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.

Full Information

First Posted
April 18, 2015
Last Updated
August 30, 2019
Sponsor
Pelvalon, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02428595
Brief Title
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Acronym
LIBERATE
Official Title
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2015 (Actual)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
July 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pelvalon, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Eclipse™ System
Intervention Type
Device
Intervention Name(s)
Eclipse™ System
Other Intervention Name(s)
Vaginal Bowel Control (VBC) Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Count of Treatment Responders in the Intent to Treat (ITT) Cohort
Description
Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Count of Treatment Responders in the Per Protocol (PP) Population
Description
Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.
Time Frame
3, 6 and 12 months
Title
Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline
Description
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.
Time Frame
12 months
Title
Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline
Description
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.
Time Frame
12 months
Title
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores
Description
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.
Time Frame
3, 6, 9 and 12 months
Other Pre-specified Outcome Measures:
Title
Safety Endpoint - Number of Device Related Adverse Events
Description
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).
Time Frame
3, 6, 9 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Richter, PhD, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Massachusetts General Hospital (MGH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
University of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Brown University (WIHRI)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Providence Sacred Heart
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25730213
Citation
Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-547. doi: 10.1097/AOG.0000000000000639.
Results Reference
background
PubMed Identifier
30807411
Citation
Richter HE, Dunivan G, Brown HW, Andy U, Dyer KY, Rardin C, Muir T, McNevin S, Paquette I, Gutman RE, Quiroz L, Wu J. A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):113-119. doi: 10.1097/SPV.0000000000000681.
Results Reference
derived
PubMed Identifier
28734829
Citation
Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.
Results Reference
derived
Links:
URL
http://journals.lww.com/greenjournal/Citation/2015/03000/A_Vaginal_Bowel_Control_System_for_the_Treatment.3.aspx
Description
A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study)

Learn more about this trial

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

We'll reach out to this number within 24 hrs