Safety and Tolerability Study of the Taris Placebo System
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Device: TARIS PlaceboProcedure: Sham Procedure
- Registration Number
- NCT01051336
- Lead Sponsor
- TARIS Biomedical, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TARIS Placebo TARIS Placebo - Sham Procedure Sham Procedure -
- Primary Outcome Measures
Name Time Method Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal 14 days
- Secondary Outcome Measures
Name Time Method Subject reported symptoms 14 days Routine and microscopic urinalysis 14 days Urine culture 14 days