Union, NJNCT04883411Now EnrollingIRB Ready

Neck Pain Clinical Trial in Union, NJ

Access cutting-edge neck pain treatment through this clinical trial at a research site in Union. Study-provided care at no cost to qualified participants.

Sponsored by ReVivo Medical, Corp.

Quick Self-Assessment

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Preparing your pre-screening questions…

Expert Care in Union

Access neck pain specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related neck pain treatment provided free

Apply for This Union Location

Check if you qualify for this neck pain clinical trial in Union, NJ

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Union

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Union site if eligible
  4. 4Begin participation

About This Neck Pain Study in Union

The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.

Sponsor: ReVivo Medical, Corp.

Who Can Participate

Inclusion Criteria

Males and females aged 22-79 years.
Documented diagnosis of cervical spine radiculopathy or myelopathy.
Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography).
Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root/spinal cord compression despite continued non-operative treatment.
Ability to speak, read, and understand the IRB approved Informed Consent document.
Willingness to give informed consent for participation in the study.

Exclusion Criteria

Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
Fewer than 2 or more than 2 vertebral levels requiring treatment.
Anatomy that is non-conducive to receiving investigational device.
More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon precludes operation or contraindicates instrumentation.
Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
Active malignancy that includes a history of any invasive malignancy (except nonmelanoma skin cancer), unless previously treated with curative intent and with no clinical signs or symptoms of the malignancy for \> 5 years.
Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).
Decompression requiring corpectomy at one or more levels.
Active systemic infection or an infection localized to the site of the proposed implantation.
Open wounds.
Signs of local inflammation.
Any diseases or conditions that would preclude accurate clinical evaluation.
Daily, high-dose oral and/or inhaled steroids or a history of chronic use of high-dose steroids.
Use of any other investigational drug or medical device within 30 days prior to surgery.
Smoking more than 1 pack of cigarettes/day.
Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.
Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
Litigation relating to spinal injury/worker's compensation.
Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C.
Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury.
Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.
Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
Suspected or documented metal allergy or intolerance.
Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
Any patient unwilling to cooperate with the post-operative instructions.
Any time implant utilization would interfere with anatomical structures or expected physiological performance.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Union?

Yes, this clinical trial (NCT04883411) has an active research site in Union, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neck Pain Treatment Options in Union, NJ

If you're searching for neck pain treatment options in Union, NJ, this clinical trial (NCT04883411) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Union research site is actively enrolling participants for this clinical trial. You'll receive care from experienced neck pain specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Ready to Join in Union?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Union, NJ