NCT00942474

Brief Summary

The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

July 20, 2009

Last Update Submit

February 18, 2014

Conditions

Cystocele

Keywords

The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement

Outcome Measures

Primary Outcomes (1)

  • Electromyography Response

    Implant

Study Arms (1)

Research Arm

EXPERIMENTAL

Facilitate nerve stimulation lead placement with the nerve access tool

Device: Facilitate nerve stimulation lead placement with the nerve access tool

Interventions

Facilitate nerve stimulation lead placement with the nerve access toolDEVICE
Research Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is equal to or greater than 18 years of age
  • Subject has a diagnosis of cystocele with planned surgical repair
  • Subject has no known deficit of the nerve
  • Subject is willing and able to provide written informed consent and HIPAA authorization to participate by signing the Informed Consent/Health Insurance Portability and Accountability Act Form after a full explanation of the nature and purpose of this study
  • Subject is willing and able to comply with the study protocol

You may not qualify if:

  • Subject has known neurological abnormalities of the nerve
  • Subject has a known allergy to the tool or neurostimulation lead components
  • Subject is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 19, 2014

Record last verified: 2014-02