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.

Trial Health

On Track

Trial Health Score

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

Enrollment

137

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach

1 country

11 active sites

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

3.2 years study duration

First Submitted

Initial submission to the registry

April 18, 2015

Completed

11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed

16 days until next milestone

Study Start

First participant enrolled

May 15, 2015

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

September 24, 2019

Completed

Last Updated

September 24, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

April 18, 2015

Results QC Date

May 9, 2019

Last Update Submit

August 30, 2019

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

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.
3 months

Secondary Outcomes (4)

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

Other Outcomes (1)

Safety Endpoint - Number of Device Related Adverse Events
3, 6, 9 and 12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Eclipse™ System

Device: Eclipse™ System

Interventions

Eclipse™ SystemDEVICE

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.

Also known as: Vaginal Bowel Control (VBC) Therapy

Treatment

Eligibility Criteria

Age19 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pelvalon, Inc.lead

Study Sites (11)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Brown University (WIHRI)

Providence, Rhode Island, 02903, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Providence Sacred Heart

Spokane, Washington, 99204, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (3)

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: 25730213BACKGROUND
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.
PMID: 30807411DERIVED
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.
PMID: 28734829DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title: Clinical Management
Organization: Pelvalon

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

April 18, 2015

First Posted

April 29, 2015

Study Start

May 15, 2015

Primary Completion

July 18, 2018

Study Completion

July 18, 2018

Last Updated

September 24, 2019

Results First Posted

September 24, 2019

Record last verified: 2019-08

Locations

US(11)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (1)

Study Arms (1)

Treatment

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (1)

Study Arms (1)

Treatment

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations