Peripheral Neuropathy Trial, Recruiting NCT05305430 Sponsor: Synergy Spine Solutions Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT05305430
Recruiting Not Applicable 🇦🇺 Australian site

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:

  • You must be over 21 years old at the time of the surgery
  • You have already had, or your doctor has decided you will have, a specific spinal disc device called the Synergy Disc implanted in your neck
  • Your bones must be fully developed, and you need disc replacement in the neck area (between the 3rd and 7th neck vertebrae) at one or more levels
  • You have persistent, hard-to-treat nerve pain and/or spinal cord pressure caused by a slipped disc or bone spurs in the neck
  • Your symptoms (such as arm or neck pain or nerve-related problems) have been confirmed by your medical history and imaging scans such as MRI, CT, or X-rays
  • You have already tried non-surgical treatments (such as physiotherapy or medication) for at least 6 weeks without enough improvement
  • You are willing and able to give written consent to participate in the study

Who may not be able to join:

  • You have moderate to severe wear and degeneration of the spine (confirm with trial site)
  • You have been diagnosed with osteoporosis (weak, brittle bones)
  • You currently have an active infection anywhere in your body or at the surgery site
  • You are pregnant
  • Your neck spine shows significant instability on X-ray images
  • You have a neck spine condition other than disc disease that would also need surgical treatment at the same level
  • You have severe damage or disease in the small joints at the back of the affected neck vertebrae
  • You have been diagnosed with low bone density (osteopenia) or softening of the bones (osteomalacia)
  • You have more than one completely immobile vertebral level in your neck from any cause
  • You are classified as morbidly obese (confirm with trial site for specific measurements)
  • You are currently incarcerated

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 5 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 Capobianco, PhD, Sponsor GmbH

Phone: +1-647-692-3493

Australian sites

Spine and Scoliosis Research Associates Australia Ltd, Windsor, Victoria

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
1 May 2022
Est. completion
1 December 2030

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Neck Disability Index; 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: 5 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