CystoceleNCT00942474
Nerve Access Tool Study
A study testing Facilitate nerve stimulation lead placement with the nerve access tool in people with Cystocele, run by MedtronicNeuro.
Trial summary
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystocele
- What is being tested?
- Facilitate nerve stimulation lead placement with the nerve access tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
- Conditions
- Cystocele
- Being tested
- Facilitate nerve stimulation lead placement with the nerve access tool
- Keywords
- The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitate nerve stimulation lead placement with the nerve access toolDevice
| Study group | Role | What they receive |
|---|---|---|
| Research Arm | Experimental | Facilitate nerve stimulation lead placement with the nerve access tool Receives: Device: Facilitate nerve stimulation lead placement with the nerve access tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography Response
Measured: Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Medtronic made a business decision to discontinue the study and withdraw the IDE.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942474
- Sponsor's protocol ID
- #1632
- Status last verified
- Feb 2014
- First submitted
- 20 Jul 2009
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool
- ClinicalTrials.gov ID
- NCT00942474
- Acronym / sponsor ID
- #1632
- Conditions
- Cystocele
- Keywords
- The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Medtronic made a business decision to discontinue the study and withdraw the IDE.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Arm | Experimental | Device: Facilitate nerve stimulation lead placement with the nerve access toolFacilitate nerve stimulation lead placement with the nerve access tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitate nerve stimulation lead placement with the nerve access tool | Device | Research Arm |
Primary outcome
Electromyography Response
Time frame: Implant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitate nerve stimulation lead placement with the nerve access tool in people with Cystocele, run by MedtronicNeuro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography Response (time frame: Implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.