Safety and Tolerability Study of the Taris Placebo System

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01051336

Run by

TARIS Biomedical, Inc.

People needed

10

Starts

2009-10-01

Expected to finish

2009-11-01

Last updated by the study team

2010-01-18

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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