Safety and Tolerability Study of the Taris Placebo System

NCT ID: NCT01051336

Last Updated: 2010-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TARIS Placebo

Group Type EXPERIMENTAL

TARIS Placebo

Intervention Type DEVICE

Sham Procedure

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TARIS Placebo

Intervention Type DEVICE

Sham Procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TARIS Biomedical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

TARIS Biomedical

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pankaj M Jain, M.D., M.B.A.

Role: PRINCIPAL_INVESTIGATOR

Dedicated Phase I (Arizona Urology)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAR-100-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.