- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01051336
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
-
-
Arizona
-
Phoenix, Arizona, United States
-
-
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
|
|
Experimental: 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
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
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Sham Procedure
-
University Hospital, ToulouseCompletedTobacco Use DisorderFrance
-
University of LeipzigReCor Medical, Inc.RecruitingHeart Failure With Preserved Ejection Fraction | Hypertension, RenalGermany
-
Fractyl Health Inc.CompletedDiabetes Mellitus, Type 2 | Noninsulin-Dependent Diabetes MellitusUnited Kingdom, Belgium, Brazil, Italy, Netherlands
-
Nantes University HospitalCompleted
-
Cytora Ltd.RecruitingMultiple System Atrophy | MSA - Multiple System AtrophyIsrael
-
Bnai Zion Medical CenterCompletedCOPD ExacerbationIsrael
-
Centre Hospitalier Universitaire de NiceAssistance Publique - Hôpitaux de Paris; Assistance Publique Hopitaux De Marseille and other collaboratorsTerminatedPulmonary Arterial HypertensionFrance
-
ProQR TherapeuticsActive, not recruitingEye Diseases | Retinitis | Eye Diseases, Hereditary | Retinal Dystrophies | Vision Disorders | Retinal Disease | Autosomal Dominant Retinitis Pigmentosa | Vision TunnelUnited States
-
Unity Health TorontoUniversity Health Network, Toronto; Sinai Health SystemUnknownHeart Failure With Normal Ejection FractionCanada
-
Asian Institute of Gastroenterology, IndiaUnknown