T-DOC® NXT Clinical Investigation

NCT ID: NCT03615001

Last Updated: 2020-06-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2018-10-04

Brief Summary

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Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Detailed Description

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Conditions

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Incontinence, Urge

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Urodynamics Arm

Group Type EXPERIMENTAL

TDOC NXT

Intervention Type DEVICE

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Interventions

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TDOC NXT

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and Female (Adult age 21+)
* Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.

Exclusion Criteria

* Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
* Patients who are pregnant
* Patients with recent (less than 2 weeks) pelvic floor surgery
* Patients who require the use of a suprapubic catheter
* Patients with significant cognitive deficiency that prevent the patient from giving informed consent
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laborie Medical Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Franklin Square Hospital/White Marsh

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TDOC-NXT-01

Identifier Type: -

Identifier Source: org_study_id

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