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Completed Not applicable Interventional Results available

A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

ClinicalTrials.gov ID: NCT00605826

Public ClinicalTrials.gov record NCT00605826. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 2, 2026, 10:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.

Study identification

NCT ID
NCT00605826
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
206 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 7, 2006 (Actual)
Primary completion
Nov 23, 2009 (Actual)
Completion
Nov 23, 2009 (Actual)
Last update posted
Aug 18, 2020

2006 – 2009

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery San Francisco California 94115 —
University of South Florida College of Medicine, Tampa General Hospital Tampa Florida 33601 —
Lahey Clinic, Department of Colon & Rectal Surgery Burlington Massachusetts 01805 —
Colon & Rectal Surgery Associates Minneapolis Minnesota 55454 —
St. Luke's/Roosevelt Hospital New York New York 10019 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Colorectal Surgical Associates Houston Texas 77054 —
Salt Lake Research/Center for Colon Rectal Disease Salt Lake City Utah 84107 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00605826, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 18, 2020 · Synced Oct 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00605826 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →