Cervical Disc DegenerationNCT05631392
Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion
An observational study of Cervical Disc Degeneration, run by Invibio Ltd at 1 site in Germany.
Trial summary
Observational data collection of information after undergoing standard Cervical spine fusion surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Disc Degeneration
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 3 Feb 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective study so patient population taken from those undergoing cervical spine fusion surgery.
Who may be able to join
- Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature.
- 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).
- 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.
- Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH).
- Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.
Who cannot join
- Subjects who have undergone previous spinal surgery either anterior or posterior.
- Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
- Subjects with a known allergy to the material used in the instrumentation.
- Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
- Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
- Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.
Observational data collection of information after undergoing standard Cervical spine fusion surgery.
- Conditions
- Cervical Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI) Questionnaire
Set of questions given to the subjects about experiencing pain during activities that are marked on a scale of 0-5 - whereby "0" is no pain and "5" is the worse pain. Maximum score for the questionnaire of "50" is possible.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start3 Feb 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invibio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NGMedical GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631392
- Sponsor's protocol ID
- NGM01
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.
- ClinicalTrials.gov ID
- NCT05631392
- Acronym / sponsor ID
- NGM01
- Conditions
- Cervical Disc Degeneration
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Invibio LtdIndustry (pharma, biotech, devices)
- Collaborators
- NGMedical GmbH
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational data collection of information after undergoing standard Cervical spine fusion surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective study so patient population taken from those undergoing cervical spine fusion surgery.
Key inclusion criteria (5 listed)
- Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature.
- 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).
- 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.
- Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH).
- Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.
Key exclusion criteria (6 listed)
- Subjects who have undergone previous spinal surgery either anterior or posterior.
- Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
- Subjects with a known allergy to the material used in the instrumentation.
- Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
- Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neck Disability Index (NDI) Questionnaire
Time frame: 24 months
Set of questions given to the subjects about experiencing pain during activities that are marked on a scale of 0-5 - whereby "0" is no pain and "5" is the worse pain. Maximum score for the questionnaire of "50" is possible.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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PMCF Study Fortilink-SC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Degeneration, run by Invibio Ltd at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI) Questionnaire (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.