Lumbar Disc HerniationNCT05549596
CETIS-I (CEra Traction Improves Spine-I)
A study testing Ceragem Master V6 Traction and Physical therapy with standard traction device in people with Lumbar Disc Herniation and Degenerative Spinal Stenosis, run by Ceragem Clinical Inc. at 1 site in South Korea.
Trial summary
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
- What is being tested?
- Ceragem Master V6 Traction and Physical therapy with standard traction device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2023to 22 May 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
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Randomized, Parallel-group, Standard Therapy Controlled, Equivalence Clinical Trials to Evaluate the Efficacy and Safety of Structural Changes in the Spine to Determine the Traction Effect of an Investigational Device, Ceragem Master V6 (CGM MB-1701) Use in Patients With Lumber Disc Herniation & Degenerative Spinal Stenosis
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis.
Read the detailed description
The efficacy and safety evaluation are conducted before and after the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day (Arm;Traction treatment) or standard physical therapy including temperature application and traction(Arm;Physical Therapy)
- Being tested
- Ceragem Master V6 Traction, Physical therapy with standard traction device
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceragem Master V6 TractionDevice
Ceragem Master V6 Traction for L2~L3
Physical therapy with standard traction deviceDevice
Physical therapy with standard traction device
| Study group | Role | What they receive |
|---|---|---|
| Traction treatment | Experimental | About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke Receives: Device: Ceragem Master V6 Traction |
| Physical Therapy | Active comparator | About 40 minutes standard physical therapy including temperature application and traction Receives: Device: Physical therapy with standard traction device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior and posterior distance changes of L2-S1 intervertebral disc
Anterior and posterior distance changes of L2-S1 intervertebral disc are evaluated through X-Ray immediately after application of medical device compared to baseline
Measured: Immediately after application
Secondary outcomes (4)
Ratio of L2-S1 Anterior/posterior intervertebral distance
Ratio of L2-S1 Anterior/posterior intervertebral distance evaluated by X-Ray immediately after application of medical device compared to baseline (A/P ratio)
Measured: Immediately after application
Changes in lower extremity radiation pain
Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline
Measured: Immediately after application
Changes in the range of waist movement
Changes in the range of waist movement evaluated by the Schober test immediately after one application of medical device compare to baseline
Measured: Immediately after application
Change in the angle evaluated by the SLR test
Change in the angle evaluated by the Straight Leg Rasing test (SLR test) modified immediately after the application of the medical device compared to the baseline
Measured: Immediately after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start3 Jan 2023
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceragem Clinical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Soon Yoon, Principal investigator, Presbyterian Medical Cente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549596
- Sponsor's protocol ID
- CC_MV6_208
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2022
- Last updated
- 5 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Parallel-group, Standard Therapy Controlled, Equivalence Clinical Trials to Evaluate the Efficacy and Safety of Structural Changes in the Spine to Determine the Traction Effect of an Investigational Device, Ceragem Master V6 (CGM MB-1701) Use in Patients With Lumber Disc Herniation & Degenerative Spinal Stenosis
- ClinicalTrials.gov ID
- NCT05549596
- Acronym / sponsor ID
- CC_MV6_208
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ceragem Clinical Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 22 Sep 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.
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis.
Detailed description
The efficacy and safety evaluation are conducted before and after the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day (Arm;Traction treatment) or standard physical therapy including temperature application and traction(Arm;Physical Therapy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traction treatment | Experimental | Device: Ceragem Master V6 TractionAbout 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke |
| Physical Therapy | Active comparator | Device: Physical therapy with standard traction deviceAbout 40 minutes standard physical therapy including temperature application and traction |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
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 |
|---|---|---|
| Ceragem Master V6 TractionCeragem Master V6 Traction for L2~L3 | Device | Traction treatment |
| Physical therapy with standard traction devicePhysical therapy with standard traction device | Device | Physical Therapy |
Primary outcome
Anterior and posterior distance changes of L2-S1 intervertebral disc
Time frame: Immediately after application
Anterior and posterior distance changes of L2-S1 intervertebral disc are evaluated through X-Ray immediately after application of medical device compared to baseline
4 secondary outcomes
Ratio of L2-S1 Anterior/posterior intervertebral distance
Time frame: Immediately after application
Changes in lower extremity radiation pain
Time frame: Immediately after application
Changes in the range of waist movement
Time frame: Immediately after application
Change in the angle evaluated by the SLR test
Time frame: Immediately after application
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 5 Feb 2026.
- Individual participant dataSharing planned: No
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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 Soon Yoon principal investigator
Presbyterian Medical Cente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceragem Master V6 Traction and Physical therapy with standard traction device in people with Lumbar Disc Herniation and Degenerative Spinal Stenosis, 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 3 inclusion and 3 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 5 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. 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?
Anterior and posterior distance changes of L2-S1 intervertebral disc (time frame: Immediately after application). 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 5 Feb 2026.