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A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage

NCT ID: NCT01475474

Last Updated: 2013-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.

Detailed Description

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Prospective, open label, single-arm, non-randomized, multi-center study designed to evaluate the efficacy, safety and tolerability of the Renew Insert in moderate-to-severe bowel incontinence patients: Minimum Wexner score of 12 AND at least weekly (score 3 or higher) leakage of solid and or liquid type stool.

Conditions

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Bowel Incontinence

Keywords

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incontinence bowel movement fecal anal diarrhea stool rectal feces uncontrolled loose leakage rectum BM watery urgent flatulence gas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Renew Insert

The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent
* Minimum Wexner Bowel incontinence score of 12 AND at least weekly (score of 3 or higher) leakage of solid and/or liquid type stool, with no greater than 50% of subjects with daily (score 4) of uncontrolled gas.
* Patients colon surveillance must be in compliance with American Cancer Society colon screening guidelines. If patient is out of compliance, they may be scheduled for Colonoscopy.
* Patient comprehends study meaning \& is capable of carrying out study duties
* Fluent in English

Exclusion Criteria

* American Society of Anesthesiologist (ASA) score of 4 or higher
* Spinal cord injury or other major neurological diagnosis
* Known immune deficiency state
* Significant cardiac arrhythmia
* Pregnant or Breastfeeding
* Inflammatory bowel disease
* Requirement of medication delivered by suppository
* Active perianal abscess or fistula
* Present rectal prolapse
* Third degree hemorrhoids
* Anal stricture
* History or rectal spasm
* Rectal surgery in past 6 months
* Unresolved Anismus
* Fecal impaction with overflow diarrhea
* Ileo-anal pouch
* Rectocele requiring surgery
* Allergy to silicone or one of its components
* Significant medical condition which interferes with study participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renew Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven D Wexner, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Emily Lukacz, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego, CA

Mark Segall, MD

Role: PRINCIPAL_INVESTIGATOR

The medical office of Mark Segall MD

Eric G Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

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Dr. Segall

Los Gatos, California, United States

Site Status

UCSD Medical Center

San Diego, California, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Countries

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United States

References

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Lukacz ES, Segall MM, Wexner SD. Evaluation of an Anal Insert Device for the Conservative Management of Fecal Incontinence. Dis Colon Rectum. 2015 Sep;58(9):892-8. doi: 10.1097/DCR.0000000000000427.

Reference Type DERIVED
PMID: 26252852 (View on PubMed)

Other Identifiers

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Renew Medical - 210CLD

Identifier Type: -

Identifier Source: org_study_id