Cervical KyphosisNCT05469295
CETIC-I (CEra Traction Improves Cervical Kyphosis -I)
A study testing CGM MB-1701 device treatment in people with Cervical Kyphosis and Cervical Lordosis, run by Ceragem Clinical Inc. at 1 site in South Korea.
Trial summary
The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cervical Kyphosis, Cervical Lordosis, Kyphosis
- What is being tested?
- CGM MB-1701 device treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2023to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
- Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
- BMI betweeen 18.5 and 30
- Chronic neck pain NRS 4 or higher lasting more than 3 months
Who cannot join
- Secondary spondylosis
- A tumor of the spine
- Inflammatory spondylitis
- Myelopathy
- Multiple adjacent radiculopathies and others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Single-blinded, Sham Device Controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 in Subjects With Cervical Kyphosis and Posterior Neck Pain.
The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior Neck Pain.
Read the detailed description
The Cervical Kyphosis are also commonly referred to as "turtle neck syndrome." It refers to the deformation of the neck bone into an inverted C-shape due to abnormalities or degenerative changes, and it is named to mean that the neck is bent like a turtle.
This device, Ceragem Master V6 (CGM MB-1701), has been certified as a combination of a personal warmer that can be used to relieve muscle pain by applying constant heat to the human body and a medical vibrator of a device that applies physical energy (vibration, shock, pressure, etc.). Also, the device got approval for use with intermittent pneumatic compression and electrically-powered orthopedics traction.
The primary purpose of this clinical trial is to confirm the temporary cervical lordosis angle improvement (height) in subjects with cervical kyphosis through the combined function of the test device.
- Conditions
- Cervical Kyphosis, Cervical Lordosis, Kyphosis
- Being tested
- CGM MB-1701 device treatment, CGM MB-1701 Sham device treatment
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM MB-1701 device treatmentDevice
This is a pre-approved motorized traction device.
CGM MB-1701 Sham device treatmentDevice
It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized.
| Study group | Role | What they receive |
|---|---|---|
| CGM_MB_1701 treatment | Experimental | Subjects will be treated with the study device for about 36 minutes. Receives: Device: CGM MB-1701 device treatment |
| Sham (CGM MB1701C) treament | Sham comparator | Subjects will be treated with the Sham device for about 36 minutes. Receives: Device: CGM MB-1701 Sham device treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of cervical lordosis
Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline.
Measured: up to 16 weeks
Secondary outcomes (3)
Change of cervical lordosis at 2nd interim analysis
Change of the cervical lordosis (posterior tangent method of Harrison) measured by cervical lateral radiography at the 2nd interim visit compared to baseline.
Measured: up to 16 weeks
Cervical vestibular angle increase more than 10 degrees
The fraction of subjects whose cervical vestibular angle measured by the posterior tangent method of Harrison at each time of evaluation increased by more than 10 degrees compared to the baseline
Measured: up to 16 weeks
Anteroposterior (T1) slope average change
Average change in cervical anteroposterior (T1) slope measured by cervical lateral radiography at each evaluation compare to the baseline
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start9 May 2023
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical KyphosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceragem Clinical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Il Shin, MD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469295
- Sponsor's protocol ID
- CRG_MV6_P03
- Status last verified
- Feb 2026
- First submitted
- 19 Jul 2022
- Last updated
- 9 Feb 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blinded, Sham Device Controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 in Subjects With Cervical Kyphosis and Posterior Neck Pain.
- ClinicalTrials.gov ID
- NCT05469295
- Acronym / sponsor ID
- CRG_MV6_P03
- Conditions
- Cervical Kyphosis, Cervical Lordosis, Kyphosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ceragem Clinical Inc.Industry (pharma, biotech, devices)
- Study start
- 9 May 2023 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 21 Jul 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.
The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior Neck Pain.
Detailed description
The Cervical Kyphosis are also commonly referred to as "turtle neck syndrome." It refers to the deformation of the neck bone into an inverted C-shape due to abnormalities or degenerative changes, and it is named to mean that the neck is bent like a turtle.
This device, Ceragem Master V6 (CGM MB-1701), has been certified as a combination of a personal warmer that can be used to relieve muscle pain by applying constant heat to the human body and a medical vibrator of a device that applies physical energy (vibration, shock, pressure, etc.). Also, the device got approval for use with intermittent pneumatic compression and electrically-powered orthopedics traction.
The primary purpose of this clinical trial is to confirm the temporary cervical lordosis angle improvement (height) in subjects with cervical kyphosis through the combined function of the test device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM_MB_1701 treatment | Experimental | Device: CGM MB-1701 device treatmentSubjects will be treated with the study device for about 36 minutes. |
| Sham (CGM MB1701C) treament | Sham comparator | Device: CGM MB-1701 Sham device treatmentSubjects will be treated with the Sham device for about 36 minutes. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
- Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
- BMI betweeen 18.5 and 30
- Chronic neck pain NRS 4 or higher lasting more than 3 months
Key exclusion criteria (5 listed)
- Secondary spondylosis
- A tumor of the spine
- Inflammatory spondylitis
- Myelopathy
- Multiple adjacent radiculopathies and others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM MB-1701 device treatmentThis is a pre-approved motorized traction device. | Device | CGM_MB_1701 treatment |
| CGM MB-1701 Sham device treatmentIt is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized. | Device | Sham (CGM MB1701C) treament |
Primary outcome
Mean change of cervical lordosis
Time frame: up to 16 weeks
Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline.
3 secondary outcomes
Change of cervical lordosis at 2nd interim analysis
Time frame: up to 16 weeks
Cervical vestibular angle increase more than 10 degrees
Time frame: up to 16 weeks
Anteroposterior (T1) slope average change
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Cervical Kyphosis
RecruitingObservational study
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Active, not recruitingObservational study
Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity
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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.
Yong Il Shin, MD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM MB-1701 device treatment in people with Cervical Kyphosis and Cervical Lordosis, run by Ceragem Clinical Inc. at 1 site in South Korea.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 9 Feb 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change of cervical lordosis (time frame: up to 16 weeks). 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 Feb 2026.