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New cage for neck surgery under observation – no treatment given

NCT ID NCT05631392

Knowledge-focused Sponsor: Invibio Ltd 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study watches 24 adults who are getting standard neck fusion surgery with a special device called the BEE HA cage. The goal is to see how well the cage helps with pain and function over time. No new treatment is tested—just careful tracking of normal surgery results.

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.

Participants

24 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

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.

Who is studied

Prospective study so patient population taken from those undergoing cervical spine fusion surgery.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature. 2. Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery). 3. Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated. 4. Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH). 5. Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief. Exclusion Criteria: 1. Subjects who have undergone previous spinal surgery either anterior or posterior. 2. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years. 3. Subjects with a known allergy to the material used in the instrumentation. 4. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study. 5. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator. 6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder radiculopathy spinal stenosis

As listed by the trial registrant

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

Cervical disc degeneration

Contacts and locations

Locations

  • Bg Klinikum Bergmannstrost Halle

    Halle, 06112, Germany

More trials for these conditions

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