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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05549596
Other study ID # CC_MV6_208
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date October 30, 2023

Study information

Verified date April 2023
Source Ceragem Inc.
Contact Hyungsun Kim
Phone +821045976672
Email khsunny1978@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.)

Study Design


Intervention

Device:
Ceragem Master V6 Traction
Ceragem Master V6 Traction for L2~L3
Physical therapy with standard traction device
Physical therapy with standard traction device

Locations

Country Name City State
Korea, Republic of Presbyterian Medical Center Jeonju

Sponsors (1)

Lead Sponsor Collaborator
Ceragem Clinical Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Immediately after application
Secondary 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) Immediately after application
Secondary Changes in lower extremity radiation pain Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline Immediately after application
Secondary 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 Immediately after application
Secondary 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 Immediately after application
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