ClinicalTrials.gg
CompletedNCT05469295Updated Feb 9, 2026

CETIC-I (CEra Traction Improves Cervical Kyphosis -I)

An interventional study of CGM MB-1701 device treatment and CGM MB-1701 Sham device treatment in Cervical Kyphosis, Cervical Lordosis and Kyphosis, sponsored by Ceragem Clinical Inc.. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Ceragem Clinical Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cervical Kyphosis
  • Cervical Lordosis
  • Kyphosis

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03

In context

Kyphosis

132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.

This study's enrollment of 30 is below the median of 44 across 82 interventional studies indexed under Kyphosis.

Browse Kyphosis studies →

Lead sponsor

Ceragem Clinical Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
  3. betweeen 18.5 and 30
  4. Chronic neck pain NRS 4 or higher lasting more than 3 months

Exclusion criteria

Exclusion Criteria:

  1. Secondary spondylosis
  2. A tumor of the spine
  3. Inflammatory spondylitis
  4. Myelopathy
  5. Multiple adjacent radiculopathies and others
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CGM_MB_1701 treatment

    Subjects will be treated with the study device for about 36 minutes.

    Device: CGM MB-1701 device treatment

  • Sham comparator
    Sham (CGM MB1701C) treament

    Subjects will be treated with the Sham device for about 36 minutes.

    Device: CGM MB-1701 Sham device treatment

Interventions

  • DeviceCGM MB-1701 device treatment

    This is a pre-approved motorized traction device.

  • DeviceCGM MB-1701 Sham device treatment

    It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 16 weeks

Secondary outcomes

  1. 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.

    Time frame: up to 16 weeks

  2. 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

    Time frame: up to 16 weeks

  3. Anteroposterior (T1) slope average change

    Average change in cervical anteroposterior (T1) slope measured by cervical lateral radiography at each evaluation compare to the baseline

    Time frame: up to 16 weeks

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Jul 2024, 14 months.

Of 58 interventional studies with no phase under Kyphosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 14 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2022
First posted
Jul 21, 2022
StartActual
May 9, 2023
Primary completionActual
Jul 26, 2024
CompletionActual
Jul 26, 2024
Last update
Feb 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05469295
Lead sponsor
Ceragem Clinical Inc.
Responsible party
Sponsor
First posted
Jul 21, 2022
Start date
May 9, 2023
Primary completion
Jul 26, 2024
Completion
Jul 26, 2024
Last update
Feb 9, 2026

Study contacts

Yong Il Shin, MD
principal investigator · Pusan National University Yangsan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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