Safety and Tolerability Study of the Taris Placebo System

January 15, 2010 updated by: TARIS Biomedical, Inc.

Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)

The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy female volunteers, 18 to 55 years of age
  • Body weight >100 lbs and BMI (body mass index) within the range 18-30 kg/m2
  • A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF)

Exclusion Criteria:

  • Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system
  • History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy)
  • History of kidney stone formation
  • Chronic or recurring bacterial or viral infections of the urogenital system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Procedure
Procedure: Sham Procedure
Experimental: TARIS Placebo
Device: TARIS Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject reported symptoms
Time Frame: 14 days
14 days
Routine and microscopic urinalysis
Time Frame: 14 days
14 days
Urine culture
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TARIS Biomedical, Inc.

Investigators

  • Principal Investigator: Pankaj M Jain, M.D., M.B.A., Dedicated Phase I (Arizona Urology)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2010

Last Update Submitted That Met QC Criteria

January 15, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TAR-100-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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