Back to resultsCETIS-I (CEra Traction Improves Spine-I)
Primary Purpose
Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ceragem Master V6 Traction
Physical therapy with standard traction device
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
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.)
Sites / Locations
- Presbyterian Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Traction treatment
Physical Therapy
Arm Description
About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke
About 40 minutes standard physical therapy including temperature application and traction
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Changes in lower extremity radiation pain
Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline
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
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
Full Information
NCT ID
NCT05549596
First Posted
September 13, 2022
Last Updated
April 28, 2023
Sponsor
Ceragem Clinical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05549596
Brief Title
CETIS-I (CEra Traction Improves Spine-I)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ceragem Clinical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traction treatment
Arm Type
Experimental
Arm Description
About 40 minutes spine traction including temperature application, Spine Scan, Pre-stroke, and Main Stroke
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
About 40 minutes standard physical therapy including temperature application and traction
Intervention Type
Device
Intervention Name(s)
Ceragem Master V6 Traction
Intervention Description
Ceragem Master V6 Traction for L2~L3
Intervention Type
Device
Intervention Name(s)
Physical therapy with standard traction device
Intervention Description
Physical therapy with standard traction device
Primary Outcome Measure Information:
Title
Anterior and posterior distance changes of L2-S1 intervertebral disc
Description
Anterior and posterior distance changes of L2-S1 intervertebral disc are evaluated through X-Ray immediately after application of medical device compared to baseline
Time Frame
Immediately after application
Secondary Outcome Measure Information:
Title
Ratio of L2-S1 Anterior/posterior intervertebral distance
Description
Ratio of L2-S1 Anterior/posterior intervertebral distance evaluated by X-Ray immediately after application of medical device compared to baseline (A/P ratio)
Time Frame
Immediately after application
Title
Changes in lower extremity radiation pain
Description
Changes in lower extremity radiation pain evaluated through VAS immediately after application of medical device compared to baseline
Time Frame
Immediately after application
Title
Changes in the range of waist movement
Description
Changes in the range of waist movement evaluated by the Schober test immediately after one application of medical device compare to baseline
Time Frame
Immediately after application
Title
Change in the angle evaluated by the SLR test
Description
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
Time Frame
Immediately after application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyungsun Kim
Phone
+821045976672
Email
khsunny1978@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sungjin Kim
Email
sungjin.kim@ceragem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Soon Yoon
Organizational Affiliation
Presbyterian Medical Cente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Medical Center
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong soon Yoon, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CETIS-I (CEra Traction Improves Spine-I)
We'll reach out to this number within 24 hrs