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Safety and Tolerability Study of the Taris Placebo System

T

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

10 participants in 2 patient groups

TARIS Placebo
Experimental group
Treatment:
Device: TARIS Placebo
Sham Procedure
Sham Comparator group
Treatment:
Procedure: Sham Procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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