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

P

Pelvalon

Status

Completed

Conditions

Fecal Incontinence

Treatments

Device: Eclipse™ System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02428595
CA005

Details and patient eligibility

About

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.

Enrollment

137 patients

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

137 participants in 1 patient group

Treatment
Experimental group
Description:
Eclipse™ System
Treatment:
Device: Eclipse™ System

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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