NCT01051336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

1 month

First QC Date

January 15, 2010

Last Update Submit

January 15, 2010

Conditions

Healthy

Keywords

TARIS PlaceboBladderInterstitial CystitisNormal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

    14 days

Secondary Outcomes (3)

  • Subject reported symptoms

    14 days

  • Routine and microscopic urinalysis

    14 days

  • Urine culture

    14 days

Study Arms (2)

TARIS Placebo

EXPERIMENTAL
Device: TARIS Placebo

Sham Procedure

SHAM COMPARATOR
Procedure: Sham Procedure

Interventions

TARIS PlaceboDEVICE
TARIS Placebo
Sham ProcedurePROCEDURE
Sham Procedure

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Pankaj M Jain, M.D., M.B.A.

    Dedicated Phase I (Arizona Urology)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

October 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 18, 2010

Record last verified: 2010-01

Locations

US(1)