Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05549596
Status:
RECRUITING
Last Update Posted:
2023-05-01
First Post:
2022-09-13
Brief Title:
CETIS-I CEra Traction Improves Spine-I
Sponsor:
Ceragem Clinical Inc
Organization:
Ceragem Inc
Study Overview
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
Status:
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:
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 ArmTraction treatment or standard physical therapy including temperature application and tractionArmPhysical Therapy
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