CETIS-I (CEra Traction Improves Spine-I)

Lumbar Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549596
• Other study ID #: CC_MV6_208
• Status: Recruiting
• Phase: N/A
• 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
• 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.)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Spinal Stenosis
• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Spinal Stenosis

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