EpilepsyPhase 2NCT00079781

RNS® System Feasibility Study

A Phase 2 study testing RNS® System implantation and RNS® System responsive stimulation in people with Epilepsy, run by NeuroPace at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The RNS® System is intended to treat patients with medically refractory (hard to treat) epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of effectiveness of the RNS® System to support the commencement of a pivotal clinical investigation. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Epilepsy
What is being tested?: RNS® System implantation and RNS® System responsive stimulation
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 12 sitesUnited States
Study dates: Jan 2004to Dec 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has simple partial seizures (motor or sensory) or complex partial seizures (with motor manifestations) with or without secondarily generalized seizures
Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or caregiver
Subject has seizures that are severe enough to cause injuries or significantly impair functional ability in domains including employment, psychosocial, education and mobility
Subject failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment
Subject has remained on the same antiseizure medication(s) over the preceding three (3) months (independent of dose and other than acute, intermittent use of benzodiazepines)
Subject has a minimum of four (4) or more countable seizures every month over the last three (3) months, as reported from the NeuroPace sponsored Prospective Seizure Frequency Clinical Investigation

Show all 16Show fewer

Subject is ≥ 18 years old and ≤ 65 years old
Subject has undergone diagnostic testing that has established the epileptiform activity onset region(s) as part of his/her standard care to determine candidacy for epilepsy surgery
Subject is male, or if female is using a reliable method of contraception (hormonal, barrier method, surgical or abstention), or is at least two years postmenopause
Subject or legal guardian is able to provide appropriate consent to participate
Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual
Subject is able to complete regular office visits and telephone appointments per the protocol requirements
Subject is willing to be implanted with the RNS® System as a treatment for his/her seizures
Subject is able to tolerate a neurosurgical procedure
Subject is considered a good candidate to be implanted with an RNS® System
Note: 1 month = 28 days

Who cannot join

Subject has been diagnosed with psychogenic or non-epileptic seizures in the preceding year
Subject has been diagnosed with primarily generalized seizures
Subject has experienced unprovoked status epilepticus in the preceding year
In the opinion of the investigator, the subject has a clinically significant or unstable medical condition or a progressive central nervous system disease
Subject has been diagnosed with active psychosis, severe depression or suicidal ideation in the preceding year
Subject is pregnant or planning on becoming pregnant in the next year

Show all 16Show fewer

Subject is on the ketogenic diet
Subject was enrolled in a therapeutic investigational drug or device study in the preceding year
Subject has an implanted Vagus Nerve Stimulator (VNS)
Subject has had therapeutic surgery to treat epilepsy in the preceding year
Subject is implanted with an electronic medical device that delivers electrical energy to the head or body
Subject is on chronic anticoagulants or, in the opinion of the investigator, subject is an unsuitable candidate for cranial surgery for any other reason
Subject had a cranial neurosurgical procedure in the previous month
Subject requires repeat MRIs
Subject's seizure onset zone(s) is/are located below the level of the subthalamic nucleus or, in the opinion of the investigator, the necessary lead placement would present too high a risk
Note: Subjects with an inactive VNS could be enrolled so long as the VNS was explanted prior to or at the same time as the RNS® System implant. Subjects who had had epilepsy surgery (resective, corpus callosotomy or ablation) greater than one year ago were still eligible.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Medical College of Georgia
Augusta, Georgia, 30912
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Rush University Medical Center / Epilepsy Center
Chicago, Illinois, 60612
Henry Ford Hospital
Detroit, Michigan, 48202
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Yale University School of Medicine
New Haven, Connecticut, 06520
Louisiana State University Epilepsy Center of Excellence
New Orleans, Louisiana, 70112
Weill Medical College of Cornell University
New York, New York, 10021
Columbia University / Columbia Presbyterian Medical Center
New York, New York, 10032
Mayo Clinic Scottsdale
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Swedish Medical Center
Seattle, Washington, 98122

Other trials in United States

About this study

Official title: RNS® System Feasibility Clinical Investigation

Read the detailed description

NeuroPace, Inc. is sponsoring an investigational device feasibility study of the RNS® System, the first closed loop responsive brain stimulator designed to treat medically refractory epilepsy. The RNS® System Feasibility study is a multi-center investigation being conducted at 12 epilepsy centers through the United States. The first 4 subjects at each site are entered into an open label protocol, and subsequent subjects at that site are entered into a randomized, double-blinded, sham-stimulation controlled protocol. The study is designed to demonstrate safety and evidence of effectiveness of the RNS® System to support commencement of a pivotal clinical investigation.

The RNS® Neurostimulator (a pacemaker-like device) and NeuroPace® Leads (tiny wires with electrodes) are implanted in the head. The Neurostimulator is a battery powered, microprocessor controlled device that detects and stores records of electrographic patterns (such as epileptiform, or seizure-like, activity) from the Leads within the brain. When the device detects an electrographic pattern, it responds by sending electrical stimulation through the Leads to a small part of the patient's brain to interrupt the electrographic pattern. This type of treatment is called responsive stimulation, but it is not yet known if it will work for the treatment of epilepsy. Direct brain stimulation therapy has already received approval in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Direct brain stimulation is not approved for the treatment of epilepsy.

Subjects participating in the RNS® System Feasibility study are required to have successfully completed the non-significant risk Prospective Seizure Frequency (PSF) study, which gathers baseline(pre-implant) seizure frequency data. Subjects must also met the inclusion criteria, including localization of epileptogenic region(s), prior to enrolling in the study. Throughout the entire study, subjects or their caregivers must keep a seizure diary. Seizure frequency, seizure severity, and antiepileptic medications, as well as physical and emotional health will be monitored and recorded throughout the study. Antiepileptic medications should continue to remain stable until 5 months post-implant.

Following enrollment, and prior to RNS® System implant, subjects undergo a neuropsychological evaluation. During the implant procedure, the RNS® Neurostimulator is cranially implanted and connected to one or two NeuroPace® Leads implanted in the brain. The investigational team determines the placement of the Leads based on prior localization of the epileptogenic region, according to standard localization procedures.

The Evaluation Period begins once the subject is implanted with the RNS® System and continues through the 4th month. Detection of epileptiform activity is enabled for all subjects within the first post-operative month. Responsive stimulation is enabled and optimized for subjects enrolled in the open label protocol or randomized to the Treatment group. Subjects randomized to the Sham group undergo simulated stimulation programming in order to maintain the treatment blind. Randomized subjects will not know whether responsive stimulation is being delivered or not.

At the beginning of the 5th month, subjects transition into the Follow up Period during which all subjects may receive responsive stimulation and antiepileptic medications may be adjusted as medically required. Subjects will be followed for 2 years post-implant. Throughout study participation, both effectiveness and safety data will be monitored continuously, and reviewed and documented by the study investigator at study appointments scheduled every 1-3 months.

Conditions: Epilepsy
Being tested: RNS® System implantation, RNS® System responsive stimulation
Keywords: Responsive Stimulation, Brain Stimulator, Epilepsy, Seizures
Medical subject headings: Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RNS® System implantationProcedure or surgery
Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.
RNS® System responsive stimulationDevice
The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.

Study groups in NCT00079781
Study group	Role	What they receive
Treatment Group	Active comparator	Group of subjects who have undergone RNS® System implantation who are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation is enabled during the first month post-implant and may continue throughout the subject's participation in the study. Receives: Procedure: RNS® System implantation; Device: RNS® System responsive stimulation
Sham Group	Sham comparator	Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation is enabled after transition into the Follow-Up Period (5th month post-implant) and may continue for the remainder of the subject's participation in the study. Receives: Procedure: RNS® System implantation
Open Label Group	Other	Group of subjects who have undergone RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study. Receives: Procedure: RNS® System implantation; Device: RNS® System responsive stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute SAE Rate
RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.
This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.
The primary safety outcome measure was met.
Measured: Initial implant through 1 month post-implant
Short-term Chronic SAE Rate
The RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.
This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.
The primary safety outcome measure was met.
Measured: Initial implant through 3 months post-implant
Responder Rate
Percentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more.
The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group.
The primary effectiveness endpoint was met.
Measured: Pre-implant baseline through 4 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Dec 2007

First posted16 Mar 2004 (estimated)
Study startJan 2004
Primary completionMay 2006
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EpilepsyStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00079781
Sponsor's protocol ID: NP10003
Status last verified: Dec 2013
First submitted: 12 Mar 2004
Last updated: 29 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Barkley GL, Smith B, Bergey G, Worrell G, Chabolla D, Drazkowski J, Labar D, Duckrow R, Murro A, Smith M, Gwinn R, Fisch B, Hirsch L, and Morrell M. Safety and Preliminary Efficacy of the RNS Responsive Neurostimulator for the Treatment of Intractable Epilepsy in Adults. Epilepsia 2006; 47(S4):5.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RNS® System Feasibility Clinical Investigation
ClinicalTrials.gov ID: NCT00079781
Acronym / sponsor ID: NP10003
Conditions: Epilepsy
Keywords: Responsive Stimulation, Brain Stimulator, Epilepsy, Seizures
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: NeuroPaceIndustry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: May 2006 (actual)
Study completion: Dec 2007 (actual)
First posted: 16 Mar 2004 (estimated)
Results: Posted 24 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Treatment Group	Active comparator	Procedure: RNS® System implantation, Device: RNS® System responsive stimulationGroup of subjects who have undergone RNS® System implantation who are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation is enabled during the first month post-implant and may continue throughout the subject's participation in the study.
Sham Group	Sham comparator	Procedure: RNS® System implantationGroup of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation is enabled after transition into the Follow-Up Period (5th month post-implant) and may continue for the remainder of the subject's participation in the study.
Open Label Group	Other	Procedure: RNS® System implantation, Device: RNS® System responsive stimulationGroup of subjects who have undergone RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Subject has simple partial seizures (motor or sensory) or complex partial seizures (with motor manifestations) with or without secondarily generalized seizures
Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or caregiver
Subject has seizures that are severe enough to cause injuries or significantly impair functional ability in domains including employment, psychosocial, education and mobility
Subject failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment
Subject has remained on the same antiseizure medication(s) over the preceding three (3) months (independent of dose and other than acute, intermittent use of benzodiazepines)

Key exclusion criteria (16 listed)

Subject has been diagnosed with psychogenic or non-epileptic seizures in the preceding year
Subject has been diagnosed with primarily generalized seizures
Subject has experienced unprovoked status epilepticus in the preceding year
In the opinion of the investigator, the subject has a clinically significant or unstable medical condition or a progressive central nervous system disease
Subject has been diagnosed with active psychosis, severe depression or suicidal ideation in the preceding year

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
RNS® System implantationUsing standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.	Procedure or surgery	Open Label Group, Sham Group, Treatment Group
RNS® System responsive stimulationThe RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.	Device	Open Label Group, Treatment Group

Primary outcome

Acute SAE Rate
Time frame: Initial implant through 1 month post-implant
RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not. This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. The primary safety outcome measure was met.
Short-term Chronic SAE Rate
Time frame: Initial implant through 3 months post-implant
The RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not. This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. The primary safety outcome measure was met.
Responder Rate
Time frame: Pre-implant baseline through 4 months post-implant
Percentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more. The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group. The primary effectiveness endpoint was met.

Results and safety

Results posted to the registry on 24 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label Group	45	42
Treatment Group	10	9
Sham Group	15	14

Primary outcome: Acute SAE Rate

Time frame: Initial implant through 1 month post-implant. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Participants n = 65
Value	6.2 (2.4 to 14.8)

Primary outcome: Short-term Chronic SAE Rate

Time frame: Initial implant through 3 months post-implant. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Participants n = 65
Value	9.2 (4.3 to 18.7)

Primary outcome: Responder Rate

Time frame: Pre-implant baseline through 4 months post-implant. Number. Unit: Percent of participants

Measure	Treatment Population n = 51
Value	24

Adverse events

Time frame: Initial implant through 2 years post-implant. Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Population	22 of 51 (43.1%)	48 of 51 (94.1%)	Not reported
Sham Group	7 of 14 (50%)	14 of 14 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationBarkley GL, Smith B, Bergey G, Worrell G, Chabolla D, Drazkowski J, Labar D, Duckrow R, Murro A, Smith M, Gwinn R, Fisch B, Hirsch L, and Morrell M. Safety and Preliminary Efficacy of the RNS Responsive Neurostimulator for the Treatment of Intractable Epilepsy in Adults. Epilepsia 2006; 47(S4):5.

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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.

Robert Goodman, MD principal investigator

Columbia University / Columbia Presbyterian Medical Center

Gregory Barkley, MD principal investigator

Henry Ford Hospital

Greg Bergey, MD principal investigator

Johns Hopkins University

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RNS® System implantation and RNS® System responsive stimulation in people with Epilepsy, run by NeuroPace at 12 sites in United States.

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 16 inclusion and 16 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: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acute SAE Rate (time frame: Initial implant through 1 month post-implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079781, which also lists 1 linked publication.

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 29 Jan 2014.