NCT01655498

Brief Summary

The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 27, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

July 24, 2012

Results QC Date

April 1, 2015

Last Update Submit

May 22, 2015

Conditions

Fecal Incontinence

Keywords

fecal incontinencebowel control

Outcome Measures

Primary Outcomes (1)

  • Frequency of FI Episodes

    Subjects with at least a 50% reduction in FI episodes (major or minor soiling)

    1 Month

Secondary Outcomes (2)

  • Number of Incontinent Days

    1 Month

  • Device-related Adverse Events

    1month

Study Arms (1)

Vaginal Bowel Control

EXPERIMENTAL

A vaginal bowel control system intended to manage fecal incontinence.

Device: vaginal bowel control system (LivSure)

Interventions

vaginal bowel control system (LivSure)DEVICE
Also known as: LivSure System, Eclipse™ System
Vaginal Bowel Control

Eligibility Criteria

Age19 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of FI for at least 6 months
  • Baseline diary requirement for min # of FI episodes in a two-week period
  • Ability to manage investigational device insertion and removal
  • Successful fitting of study device
  • Willing and able to give written informed consent to participate in the study

You may not qualify if:

  • Chronic rectal, anal or pelvic pain
  • Any vaginal prolapse that extends beyond the plane of the hymen.
  • Previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer)
  • Congenital anorectal malformation
  • Chronic watery diarrhea unmanageable by drugs or diet as primary cause of FI
  • Inflammatory bowel disease
  • Presence of a vaginal, anal, rectal or urethral fistula or anastomosis
  • Presence of a vaginal, rectal or bladder tumor
  • Presence of an open wound or tear in the vagina or anus by exam
  • Presence or history of rectovaginal fistula
  • Atrophic vaginal tissue as determined by symptoms or visualization
  • Current vaginal or urinary infection requiring treatment
  • History of recurrent urinary or vaginal infections
  • Subject is currently pregnant or planning pregnancy in next 5 months
  • Concurrent use of any intra-vaginal device that would interfere with LivSure (now called Eclipse) placement or wearing
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (2)

  • Matthews CA, Varma MG, Takase-Sanchez MM, Hale DS, Van Drie D, Muir T, Wells E, Jannelli M, Richter HE. Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):359-63. doi: 10.1097/SPV.0000000000000290.

    PMID: 27564386DERIVED

  • 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.

    PMID: 25730213DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Director of Clinical
Organization
Pelvalon
650-276-0130

Study Officials

  • Holly Richter, PhD, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

August 2, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

May 27, 2015

Results First Posted

May 27, 2015

Record last verified: 2015-05

Locations

US(1)