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Completed

NCT Number: NCT01051336

Safety and Tolerability Study of the Taris Placebo System

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.

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Key information

Conditions

Healthy Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TARIS Placebo

Device

Sham Procedure

Procedure

Primary outcomes

  1. Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal

    Time frame: 14 days

Secondary outcomes

  1. Subject reported symptoms

    Time frame: 14 days

  2. Routine and microscopic urinalysis

    Time frame: 14 days

  3. Urine culture

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

TARIS Biomedical, Inc.

Industry

Registry information

Official study title

Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2010
Registry last updated
Jan 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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