Healthy
Conditions
Keywords
TARIS Placebo, Bladder, Interstitial Cystitis, Normal Healthy Volunteers
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.
Interventions
DEVICETARIS Placebo
PROCEDURESham Procedure
Sponsors
TARIS Biomedical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Subject reported symptoms | 14 days |
| Routine and microscopic urinalysis | 14 days |
| Urine culture | 14 days |
Countries
United States
Outcome results
None listed