RadiculopathyPhase 3NCT00578812
PCM Cervical Disc System
A Phase 3 study testing Anterior Cervical Discectomy and Fusion (ACDF) and PCM Cervical Disc in people with Radiculopathy and Myelopathy, run by NuVasive at 23 sites in United States.
Trial summary
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy, Myelopathy
- What is being tested?
- Anterior Cervical Discectomy and Fusion (ACDF) and PCM Cervical Disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 23 sitesUnited States
- Study dates
- Jan 2005to Aug 2014
- Phase
- Phase 3
- 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
- Age 18-65 years;
- Diagnosis of radiculopathy or myelopathy of the cervical spine between C3-4 and C7-T1;
- Symptomatic at only one level from C3-C4 to C7-T1;
- Unresponsive to non-operative treatment for six weeks, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment;
- Baseline NDI score of ≥30/100;
- Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following: decreased disc height, degenerative spondylosis on CT or MRI, or disc herniation;
Show all 9Show fewer
- Appropriate for treatment using an anterior surgical approach, including having no more than one previous anterior surgical approach to the cervical spine;
- Ability and willingness to comply with follow-up regimen; and
- Written informed consent given by subject or subject's legally authorized representative.
Who cannot join
- Infection at the site of surgery;
- History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;
- Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion;
- More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;
- Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;
- Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy justifying the need for surgical intervention;
Show all 25Show fewer
- Radiographic confirmation of severe facet joint disease or degeneration.
- Osteoporosis:
- Severe diabetes mellitus requiring daily insulin management;
- Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
- Tumor as source of symptoms;
- Symptomatic DDD or significant cervical spondylosis at two or more levels;
- Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;
- Severe myelopathy to the extent that the patient is wheelchair bound;
- Pregnant (verified in patients of childbearing potential by a negative urine pregnancy test when preadmission testing is obtained), or interested in becoming pregnant during the duration of the study;
- Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis);
- Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;
- Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;
- Previous spine surgery within the 6 months preceding the cervical randomized procedure;
- Current or recent history of substance abuse (drug or alcohol);
- Morbid obesity, defined as body mass index ("BMI") > 40 or more than 100 lbs. over ideal body weight;
- Currently using, or planning to use, bone growth stimulators in the cervical spine;
- Use of any other investigational drug or medical device within the last 30 days prior to surgery
- Currently a prisoner; or
- Currently pursuing personal litigation related to the neck or cervical spine injury; however, involvement in worker's compensation related litigation is not a required exclusion.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
NeuroSpine Center of Wisconsin
Appleton, Wisconsin, 54913
Tower Orthopedics
Beverly Hills, California, 90211
Spine Group Beverly Hills
Beverly Hills, California, 90212
Midwest Orthopedic Associates at Rush
Chicago, Illinois, 60612
Chicago Back Institute
Chicago, Illinois, 60625
The Cleveland Clinic
Cleveland, Ohio, 44195
Columbia Orthopedic Research
Columbia, Missouri, 65201
Denver Spine
Greenwood Village, Colorado, 80111
Goodman Campbell Brain and Spine
Indianapolis, Indiana, 46260
Buffalo Spine Surgery
Lockport, New York, 14094
Neuroscience Specialists
Oklahoma City, Oklahoma, 73120
Olympia Othopaedic Associates
Olympia, Washington, 98502
The Rothman Institute
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
Neurosurgical Associates of San Antonio
San Antonio, Texas, 78229
Wm. Beaumont Hospital
Southfield, Michigan, 48034
Institute for Spine Care
Syracuse, New York, 13202
Madigan Army Medical Center
Tacoma, Washington, 98431-1100
Scott and White Memorial Hospital
Temple, Texas, 76508
Towson Orthopedic Associates
Towson, Maryland, 21204
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
OrthoNeuro
Westerville, Ohio, 43054
Virginia Brain and Spine
Winchester, Virginia, 22601
About this study
Official title: A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM® Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: 2 Year Results From the US IDE Clinical Trial
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
Read the detailed description
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
Patients were evaluated before surgery, during the operation, immediately after surgery, and then at 6 weeks, 3 months, 6 months, 12 months and 24 months, and yearly after surgery. The patients were recommended to have a physical therapy program for non-impact exercises and active range of motion exercises after surgery. Patients were also instructed to avoid repetitive cervical flexion and extension bending and lateral bending and rotation for 6 weeks following surgery.
The safety of the PCM Cervical Disc was assessed by comparing the adverse events, any additional surgical procedures, and the neurological outcomes to those in the ACDF control group. The effectiveness of the PCM Cervical Disc was assessed by evaluating patients' pain and function outcomes using a standard questionnaire, the Neck Disability Index (NDI), the severity of neck and arm pain based on a Visual Analog Scale (VAS) assessment, quality of life using a standard questionnaire, the Short Form-36 (SF-36), as well as a patient satisfaction questionnaire compared to the ACDF control group. In addition, the patients were evaluated using radiographic evaluations, including spinal range of motion, spinal disc height, device displacement or migration, spinal fusion status, and heterotopic ossification (abnormal bone formation).
The primary endpoint of the IDE trial was a composite measure termed "overall success," which was evaluated at 24 months postoperatively, and was defined as at least 20% improvement in neck disability index (NDI) from preoperative score; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period.
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.
- Conditions
- Radiculopathy, Myelopathy
- Being tested
- Anterior Cervical Discectomy and Fusion (ACDF), PCM Cervical Disc
- Medical subject headings
- Radiculopathy, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Discectomy and Fusion (ACDF)Device
Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
PCM Cervical DiscDevice
PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
| Study group | Role | What they receive |
|---|---|---|
| PCM Cervical Disc - Investigational | Experimental | PCM Cervical Disc replacement at one level from C3 to T1 Receives: Device: PCM Cervical Disc |
| ACDF - Control Group | Active comparator | Anterior cervical discectomy and fusion (ACDF) at one level from C3 to T1 Receives: Device: Anterior Cervical Discectomy and Fusion (ACDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Patient Overall Success
Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.
Measured: 24 Months
Secondary outcomes (15)
Neck Pain Visual Analog Scale
Improvement of ≥20mm in neck pain at 24 months compared to baseline.
Measured: 24 Months
Mean Neck Pain Visual Analog Scale
Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).
Measured: 24 Months
Worst Arm Pain Visual Analog Scale
Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.
Measured: 24 Months
Mean Worst Arm Pain Visual Analog Scale
Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).
Measured: 24 Months
Clinically Significant Improvement on Neck Disability Index (NDI)
Improvement in NDI of ≥20% at 24 months compared to baseline.
Measured: 24 Months
Clinically Significant Improvement on Neck Disability Index (NDI)
Improvement in NDI of ≥15-points at 24 months compared to baseline.
Measured: 24 Months
Mean Neck Disability Index (NDI)
Mean NDI at 24 months on a 0-100 scale (lower value is better).
Measured: 24 Months
Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)
Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.
Measured: 24 Months
Mean SF-36 Physical Component Summary (PCS)
Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).
Measured: 24 Months
Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)
Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.
Measured: 24 Months
Mean SF-36 Mental Component Summary (MCS)
Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).
Measured: 24 Months
Dysphagia for Swallowing
Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).
Measured: 24 Months
Patient Satisfaction
Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).
Measured: 24 Months
Nurick's Classification of Disability (Myelopathy)
Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick's classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient "maintained" if their Nurick classification grade remained the same or "improved" if it decreased from baseline to 24 months.
Measured: 24 Months
Flexion/Extension Range of Motion at the Operative Level
Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startJan 2005
- Primary completionMar 2010
- Study completionAug 2014
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.
- Other trials for RadiculopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578812
- Sponsor's protocol ID
- G040081
- Status last verified
- Jun 2015
- First submitted
- 19 Dec 2007
- Last updated
- 7 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM® Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: 2 Year Results From the US IDE Clinical Trial
- ClinicalTrials.gov ID
- NCT00578812
- Acronym / sponsor ID
- G040081
- Conditions
- Radiculopathy, Myelopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 12 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
Detailed description
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
Patients were evaluated before surgery, during the operation, immediately after surgery, and then at 6 weeks, 3 months, 6 months, 12 months and 24 months, and yearly after surgery. The patients were recommended to have a physical therapy program for non-impact exercises and active range of motion exercises after surgery. Patients were also instructed to avoid repetitive cervical flexion and extension bending and lateral bending and rotation for 6 weeks following surgery.
The safety of the PCM Cervical Disc was assessed by comparing the adverse events, any additional surgical procedures, and the neurological outcomes to those in the ACDF control group. The effectiveness of the PCM Cervical Disc was assessed by evaluating patients' pain and function outcomes using a standard questionnaire, the Neck Disability Index (NDI), the severity of neck and arm pain based on a Visual Analog Scale (VAS) assessment, quality of life using a standard questionnaire, the Short Form-36 (SF-36), as well as a patient satisfaction questionnaire compared to the ACDF control group. In addition, the patients were evaluated using radiographic evaluations, including spinal range of motion, spinal disc height, device displacement or migration, spinal fusion status, and heterotopic ossification (abnormal bone formation).
The primary endpoint of the IDE trial was a composite measure termed "overall success," which was evaluated at 24 months postoperatively, and was defined as at least 20% improvement in neck disability index (NDI) from preoperative score; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period.
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCM Cervical Disc - Investigational | Experimental | Device: PCM Cervical DiscPCM Cervical Disc replacement at one level from C3 to T1 |
| ACDF - Control Group | Active comparator | Device: Anterior Cervical Discectomy and Fusion (ACDF)Anterior cervical discectomy and fusion (ACDF) at one level from C3 to T1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65 years;
- Diagnosis of radiculopathy or myelopathy of the cervical spine between C3-4 and C7-T1;
- Symptomatic at only one level from C3-C4 to C7-T1;
- Unresponsive to non-operative treatment for six weeks, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment;
- Baseline NDI score of ≥30/100;
Key exclusion criteria (25 listed)
- Infection at the site of surgery;
- History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;
- Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion;
- More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;
- Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;
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 |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF)Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1 | Device | ACDF - Control Group |
| PCM Cervical DiscPCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1 | Device | PCM Cervical Disc - Investigational |
Primary outcome
Individual Patient Overall Success
Time frame: 24 Months
Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.
15 secondary outcomes
Neck Pain Visual Analog Scale
Time frame: 24 Months
Mean Neck Pain Visual Analog Scale
Time frame: 24 Months
Worst Arm Pain Visual Analog Scale
Time frame: 24 Months
Mean Worst Arm Pain Visual Analog Scale
Time frame: 24 Months
Clinically Significant Improvement on Neck Disability Index (NDI)
Time frame: 24 Months
Clinically Significant Improvement on Neck Disability Index (NDI)
Time frame: 24 Months
Mean Neck Disability Index (NDI)
Time frame: 24 Months
Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)
Time frame: 24 Months
Mean SF-36 Physical Component Summary (PCS)
Time frame: 24 Months
Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)
Time frame: 24 Months
Mean SF-36 Mental Component Summary (MCS)
Time frame: 24 Months
Dysphagia for Swallowing
Time frame: 24 Months
Patient Satisfaction
Time frame: 24 Months
Nurick's Classification of Disability (Myelopathy)
Time frame: 24 Months
Flexion/Extension Range of Motion at the Operative Level
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NuVasiveLink provided by the sponsor.
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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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anterior Cervical Discectomy and Fusion (ACDF) and PCM Cervical Disc in people with Radiculopathy and Myelopathy, run by NuVasive at 23 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 9 inclusion and 25 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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 12 Feb 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?
Individual Patient Overall Success (time frame: 24 Months). 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 7 Jul 2015.