Safety and Tolerability Study of the Taris Placebo System | NCT01051336

Studies
Safety and Tolerability Study of the Taris Placebo System

NCT01051336

Sponsor

TARIS Biomedical, Inc.

Status

Completed

Last Update Posted

Jan 18, 2010Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Healthy

Interventions

TARIS Placebo
Sham Procedure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jan 15, 2010

First Submission Date that Met QC Criteria

Jan 15, 2010

First Posted Date

Jan 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2010

Last Update Posted Date

Jan 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TARIS Placebo	Experimental		Device: TARIS Placebo
Sham Procedure	Sham Comparator		Procedure: Sham Procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TARIS Placebo	Device		TARIS Placebo
Sham Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal		14 days

Secondary Outcomes

Measure	Description	Time Frame
Subject reported symptoms		14 days
Routine and microscopic urinalysis		14 days
Urine culture

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pankaj M Jain, M.D., M.B.A.	Dedicated Phase I (Arizona Urology)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided