CETIC-I (CEra Traction Improves Cervical Kyphosis -I)
Primary Purpose
Cervical Kyphosis, Cervical Lordosis, Kyphosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CGM MB-1701 device treatment
CGM MB-1701 Sham device treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Kyphosis
Eligibility Criteria
Inclusion Criteria:
- Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
- Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
- BMI betweeen 18.5 and 30
- Swallowing Impairment Index-6, at least 1 point out of 6 items
Exclusion Criteria:
- Secondary spondylosis
- A tumor of the spine
- Inflammatory spondylitis
- Myelopathy
- Multiple adjacent radiculopathies and others
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
CGM_MB_1701 treatment
Sham (CGM MB1701C) treament
Arm Description
Subjects will be treated with the study device for about 36 minutes.
Subjects will be treated with the Sham device for about 36 minutes.
Outcomes
Primary Outcome Measures
Mean change of cervical lordosis
Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline.
Secondary Outcome Measures
Change of cervical lordosis at 2nd interim analysis
Change of the cervical lordosis (posterior tangent method of Harrison) measured by cervical lateral radiography at the 2nd interim visit compared to baseline.
Cervical vestibular angle increase more than 10 degrees
The fraction of subjects whose cervical vestibular angle measured by the posterior tangent method of Harrison at each time of evaluation increased by more than 10 degrees compared to the baseline
Anteroposterior (T1) slope average change
Average change in cervical anteroposterior (T1) slope measured by cervical lateral radiography at each evaluation compare to the baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05469295
Brief Title
CETIC-I (CEra Traction Improves Cervical Kyphosis -I)
Official Title
A Prospective, Randomized, Single-blinded, Sham Device Controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 in Subjects With Cervical Kyphosis and Posterior Neck Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
June 28, 2023 (Anticipated)
Study Completion Date
November 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
5. Study Description
Brief Summary
The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior Neck Pain.
Detailed Description
The Cervical Kyphosis are also commonly referred to as "turtle neck syndrome." It refers to the deformation of the neck bone into an inverted C-shape due to abnormalities or degenerative changes, and it is named to mean that the neck is bent like a turtle.
This device, Ceragem Master V6 (CGM MB-1701), has been certified as a combination of a personal warmer that can be used to relieve muscle pain by applying constant heat to the human body and a medical vibrator of a device that applies physical energy (vibration, shock, pressure, etc.). Also, the device got approval for use with intermittent pneumatic compression and electrically-powered orthopedics traction.
The primary purpose of this clinical trial is to confirm the temporary cervical lordosis angle improvement (height) in subjects with cervical kyphosis through the combined function of the test device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Kyphosis, Cervical Lordosis, Kyphosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CGM_MB_1701 treatment
Arm Type
Experimental
Arm Description
Subjects will be treated with the study device for about 36 minutes.
Arm Title
Sham (CGM MB1701C) treament
Arm Type
Sham Comparator
Arm Description
Subjects will be treated with the Sham device for about 36 minutes.
Intervention Type
Device
Intervention Name(s)
CGM MB-1701 device treatment
Intervention Description
This is a pre-approved motorized traction device.
Intervention Type
Device
Intervention Name(s)
CGM MB-1701 Sham device treatment
Intervention Description
It is manufactured in the same way as the test device and the operation pattern. However, the actual effect of the massage is minimized.
Primary Outcome Measure Information:
Title
Mean change of cervical lordosis
Description
Mean change of cervical lordosis using posterior tangent method of Harrison measured by cervical lateral radiography at EOT (End of Trial) compared to baseline.
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Change of cervical lordosis at 2nd interim analysis
Description
Change of the cervical lordosis (posterior tangent method of Harrison) measured by cervical lateral radiography at the 2nd interim visit compared to baseline.
Time Frame
up to 16 weeks
Title
Cervical vestibular angle increase more than 10 degrees
Description
The fraction of subjects whose cervical vestibular angle measured by the posterior tangent method of Harrison at each time of evaluation increased by more than 10 degrees compared to the baseline
Time Frame
up to 16 weeks
Title
Anteroposterior (T1) slope average change
Description
Average change in cervical anteroposterior (T1) slope measured by cervical lateral radiography at each evaluation compare to the baseline
Time Frame
up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
BMI betweeen 18.5 and 30
Chronic neck pain NRS 4 or higher lasting more than 3 months
Exclusion Criteria:
Secondary spondylosis
A tumor of the spine
Inflammatory spondylitis
Myelopathy
Multiple adjacent radiculopathies and others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyungsun Kim
Phone
82-10-4597-6672
Email
hyungsun.kim@ceragem.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sungjin Kim
Phone
82-10-5538-7042
Email
sungjun.kim@ceragem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Il Shin, MD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CETIC-I (CEra Traction Improves Cervical Kyphosis -I)
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