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New Back-Pain device could offer Drug-Free relief

NCT ID NCT05549596

Symptom relief Sponsor: Ceragem Clinical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device called Ceragem Master V6 that gently stretches the spine in people with herniated discs or spinal stenosis. 60 adults were randomly assigned to use the new device or standard physical therapy. The goal was to see if the device could improve spine structure and reduce leg pain right after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ceragem Master V6 traction device
What this could lead to
If it works, this could offer a new non-surgical option for relieving spine pressure and pain from herniated discs or spinal stenosis.
What could go wrong
This is a small, early-stage trial with only 60 people, so results may not apply widely. The device is compared to standard traction, and equivalence does not guarantee it is better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jan 2023

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject who has been diagnosed with intervertebral disc herniation or degenerative stenosis (a person who has been diagnosed in the past or has been diagnosed upon obtaining consent) * Adult men and women over 19 years of age * Body mass index (BMI) 18.5 over to less than 30 Exclusion Criteria: * Subject with fibromyalgia, dystonia, and epilepsy * Subject with sensory impairment * Subject with physical irritation-induced skin lesions such as fever and compression (dermatosis, compression urticaria, choline urticaria, fever urticaria, etc.)

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Conditions

The condition(s) this trial relates to.

Intervertebral Disc Displacement lumbar disk disease lumbar disk herniation, susceptibility to lumbar spinal stenosis spinal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative spinal stenosis Lumbar disc herniation Spine traction

Contacts and locations

Locations

  • Presbyterian Medical Center

    Jeonju, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.