Safety and Tolerability Study of the Taris Placebo System
NCT ID: NCT01051336
Last Updated: 2010-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2009-10-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TARIS Placebo
TARIS Placebo
Sham Procedure
Sham Procedure
Interventions
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TARIS Placebo
Sham Procedure
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
FEMALE
Yes
Sponsors
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TARIS Biomedical, Inc.
INDUSTRY
Responsible Party
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TARIS Biomedical
Principal Investigators
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Pankaj M Jain, M.D., M.B.A.
Role: PRINCIPAL_INVESTIGATOR
Dedicated Phase I (Arizona Urology)
Locations
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Phoenix, Arizona, United States
Countries
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Other Identifiers
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TAR-100-101
Identifier Type: -
Identifier Source: org_study_id
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