Safety and Tolerability Study of the Taris Placebo System

Taris Biomedical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: TARIS Placebo; Procedure: Sham Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT01051336

TAR-100-101

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

TARIS Placebo

Experimental group

Treatment:

Device: TARIS Placebo

Sham Procedure

Sham Comparator group

Treatment:

Procedure: Sham Procedure