Injectable Bulking Agent Needle Guide (NG)

Carbon Medical Technologies

Status and phase: Terminated; Phase 1

Conditions: Intrinsic Sphincter Deficiency; Urinary Incontinence

Treatments: Device: Needle Guided Periurethral Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763711

P1006

Details and patient eligibility

About

The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.

Enrollment: 17 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Injection with Needle Guide

Experimental group

Treatment:

Device: Needle Guided Periurethral Injection