CETIS-I (CEra Traction Improves Spine-I)

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation; Degenerative Spinal Stenosis; Spine Traction
• Intervention / Treatment: Device: Ceragem Master V6 Traction; Device: Physical therapy with standard traction device

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Jeonju, South Korea
    • Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traction treatment; About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke	Device: Ceragem Master V6 Traction; Ceragem Master V6 Traction for L2~L3
Active Comparator: Physical Therapy; About 40 minutes standard physical therapy including temperature application and traction	Device: Physical therapy with standard traction device; Physical therapy with standard traction device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Ceragem Clinical Inc.
• Investigators: Principal Investigator: Yong Soon Yoon, Presbyterian Medical Cente

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Intervertebral Disc Displacement; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: CC_MV6_208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No