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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
Ceragem Clinical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Kyphosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
  3. BMI betweeen 18.5 and 30
  4. Swallowing Impairment Index-6, at least 1 point out of 6 items

Exclusion Criteria:

  1. Secondary spondylosis
  2. A tumor of the spine
  3. Inflammatory spondylitis
  4. Myelopathy
  5. 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

    First Posted
    July 19, 2022
    Last Updated
    April 28, 2023
    Sponsor
    Ceragem Clinical Inc.
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    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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