NCT05549596

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ceragem Clinical Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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)

Conditions

• Lumbar Disc Herniation
• Degenerative Spinal Stenosis
• Spine Traction

Interventions

Type	Name	Description
DEVICE	Ceragem Master V6 Traction	Ceragem Master V6 Traction for L2\~L3
DEVICE	Physical therapy with standard traction device	Physical therapy with standard traction device

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2022-09-22
• Last updated: 2026-02-05

Locations

1 site across 1 country: South Korea