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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

January 15, 2010
January 15, 2010
October 2009
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability Study of the Taris Placebo System
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy
  • Device: TARIS Placebo
  • Procedure: Sham Procedure
  • Experimental: TARIS Placebo
    Intervention: Device: TARIS Placebo
  • Sham Comparator: Sham Procedure
    Intervention: Procedure: Sham Procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01051336
TAR-100-101
No
Julie Himes, M.D. / Chief Medical Officer, TARIS Biomedical
TARIS Biomedical, Inc.
Not Provided
Principal Investigator: Pankaj M Jain, M.D., M.B.A. Dedicated Phase I (Arizona Urology)
TARIS Biomedical, Inc.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP