Safety and Tolerability Study of the Taris Placebo System

This study has been completed.
Sponsor:
Information provided by:
TARIS Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01051336
First received: January 15, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Device: TARIS Placebo
Procedure: Sham Procedure
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)

Further study details as provided by TARIS Biomedical, Inc.:

Primary Outcome Measures:
  • Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subject reported symptoms [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Routine and microscopic urinalysis [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Urine culture [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TARIS Placebo Device: TARIS Placebo
Sham Comparator: Sham Procedure Procedure: Sham Procedure

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051336

Locations
United States, Arizona
Phoenix, Arizona, United States
Sponsors and Collaborators
TARIS Biomedical, Inc.
Investigators
Principal Investigator: Pankaj M Jain, M.D., M.B.A. Dedicated Phase I (Arizona Urology)
  More Information

No publications provided

Responsible Party: Julie Himes, M.D. / Chief Medical Officer, TARIS Biomedical
ClinicalTrials.gov Identifier: NCT01051336     History of Changes
Other Study ID Numbers: TAR-100-101
Study First Received: January 15, 2010
Last Updated: January 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by TARIS Biomedical, Inc.:
TARIS Placebo
Bladder
Interstitial Cystitis
Normal Healthy Volunteers

ClinicalTrials.gov processed this record on August 01, 2014