Fecal IncontinenceLIBERATENCT02428595

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

A study testing Eclipse™ System in people with Fecal Incontinence, run by Pelvalon, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 years and older, women only
Conditions the study is for: Fecal Incontinence
What is being tested?: Eclipse™ System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 11 sitesUnited States
Study dates: 15 May 2015to 18 Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

University of New Mexico
Albuquerque, New Mexico, 87131
University of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Christ Hospital
Cincinnati, Ohio, 45219
Houston Methodist
Houston, Texas, 77030
University of Wisconsin
Madison, Wisconsin, 53792
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brown University (WIHRI)
Providence, Rhode Island, 02903
University of North Carolina
Raleigh, North Carolina, 27607
Providence Sacred Heart
Spokane, Washington, 99204

Other trials in United States

About this study

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.

Conditions: Fecal Incontinence
Being tested: Eclipse™ System
Medical subject headings: Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eclipse™ SystemDevice
Also called Vaginal Bowel Control (VBC) Therapy
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.

Study groups in NCT02428595
Study group	Role	What they receive
Treatment	Experimental	Eclipse™ System Receives: Device: Eclipse™ System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (4)

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.
Measured: 3, 6 and 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 3, 6, 9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 201518 Jul 2018

First posted29 Apr 2015 (estimated)
Study start15 May 2015
Primary completion18 Jul 2018
Study completion18 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02428595
Sponsor's protocol ID: CA005
Acronym: LIBERATE
Status last verified: Aug 2019
First submitted: 18 Apr 2015
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25730213
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.
PubMed 30807411
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.
PubMed 28734829

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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All Fecal Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
ClinicalTrials.gov ID: NCT02428595
Acronym / sponsor ID: LIBERATE / CA005
Conditions: Fecal Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Pelvalon, Inc.Industry (pharma, biotech, devices)
Study start: 15 May 2015 (actual)
Primary completion: 18 Jul 2018 (actual)
Study completion: 18 Jul 2018 (actual)
First posted: 29 Apr 2015 (estimated)
Results: Posted 24 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: Eclipse™ SystemEclipse™ System

Who may qualify

Ages: 19 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eclipse™ SystemAlso: Vaginal Bowel Control (VBC) TherapyThe 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.	Device	Treatment

Primary outcome

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.

4 secondary outcomes

Count of Treatment Responders in the Per Protocol (PP) Population
Time frame: 3, 6 and 12 months
Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline
Time frame: 12 months
Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline
Time frame: 12 months
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores
Time frame: 3, 6, 9 and 12 months

Results and safety

Results posted to the registry on 24 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	137	73

Primary outcome: Count of Treatment Responders in the Intent to Treat (ITT) Cohort

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Intent to Treat n = 73
Value	53

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events were collected for the full duration of study, including the fitting and treatment periods, for a total participation of 3.5-15 months (typically 13 months). For further detail, the fitting period, which occurs first, requires 2-4 weeks, but can be repeated up to 3 times, for a total of 2-12 weeks in this phase (typically 4 weeks). The treatment period, which follows the fitting period, is a minimum of 3 months and up to 12 months (typically 12 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fitting	0 of 137 (0%)	62 of 137 (45.3%)	0 of 137
Treatment	8 of 73 (11%)	28 of 73 (38.4%)	0 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25730213Richter 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.
Derived from this study: PubMed 30807411Richter 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.
Derived from this study: PubMed 28734829Antosh 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.
A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study)Link provided by the sponsor.

Related trials for Fecal Incontinence

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Richter, PhD, MD principal investigator

University of Alabama at Birmingham

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Eclipse™ System in people with Fecal Incontinence, run by Pelvalon, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of Treatment Responders in the Intent to Treat (ITT) Cohort (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02428595, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.