Peripheral Neuropathy Trial, Recruiting NCT06383949 Sponsor: Synergy Spine Solutions Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT06383949
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 21 years of age or older at the time of surgery.
  • People who have already had a specific spinal disc implant called the Synergy Disc placed in their neck, or for whom a doctor has already decided this implant will be used.
  • People who are fully grown (skeletally mature) and are having one or more discs in the neck (between levels C3 and C7) replaced after disc removal surgery.
  • People experiencing persistent, hard-to-treat nerve pain and/or spinal cord pressure in the neck, caused by a herniated disc and/or bony growths pressing on nerves or the spinal cord.
  • People whose nerve or spinal cord compression has been confirmed both by their symptoms (such as arm or neck pain, or neurological changes) and by imaging tests such as MRI, CT, or X-rays.
  • People who have already tried at least 6 weeks of non-surgical treatment without sufficient relief.
  • People who have provided written consent to take part in the trial.

Who may not be able to join:

  • People with moderate to advanced spinal degeneration in the neck.
  • People who have been diagnosed with osteoporosis (low bone density).
  • People with an active infection anywhere in the body, or at the surgical site.
  • People who are pregnant.
  • People who have significant instability in the neck shown on X-rays.
  • People with a neck spine condition other than symptomatic disc disease that would also require surgery at the same level.
  • People with severe damage or disease of the small joints at the back of the spine at the affected level.
  • People previously diagnosed with osteopenia or osteomalacia (conditions involving reduced bone strength or softening of bones).
  • People who have more than one completely immobile vertebral level in the neck or upper spine (between C1 and T1) for any reason.
  • People with morbid obesity.
  • People considered vulnerable, including those who are pregnant, children, prisoners, people brought in as emergency cases, or people who do not have the mental capacity to consent.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Robyn M Capobianco, PhD, Synergy Spine Solutions

Phone: (720) 787-9063

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Synergy Spine Solutions
Registry
ClinicalTrials.gov
Start date
6 August 2024
Est. completion
23 February 2028

Where this trial is recruiting

🇮🇪 Ireland

Primary endpoints

Neck Disability Index (NDI); Device Related or Device Procedure Related Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov