Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05469295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-01
First Post:
2022-07-19
Brief Title:
CETIC-I CEra Traction Improves Cervical Kyphosis -I
Sponsor:
Ceragem Clinical Inc
Organization:
Ceragem Inc
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None