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A prospective, randomized, single-blinded, sham device (CGM MB-1901C, sham device of CGM MB-1901) controlled, parallel treatment grouped, multi-center, superiority, confirmatory clinical trial to evaluate efficacy and safety of CGM MB-1901 in patients with non-specific low back pain

Status Approved

First Submitted Date

2021/02/18
Registered Date

2021/02/22
Last Updated Date

2022/07/28

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005926
Unique Protocol ID	CRG_MV4_P01
Public/Brief Title	A prospective, randomized, single-blinded, sham device (CGM MB-1901C, sham device of CGM MB-1901) controlled, parallel treatment grouped, multi-center, superiority, confirmatory clinical trial to evaluate efficacy and safety of CGM MB-1901 in patients with non-specific low back pain
Scientific Title	A prospective, randomized, single-blinded, sham device (CGM MB-1901C, sham device of CGM MB-1901) controlled, parallel treatment grouped, multi-center, superiority, confirmatory clinical trial to evaluate efficacy and safety of CGM MB-1901 in patients with non-specific low back pain
Acronym	CRG_MV4_P01
MFDS Regulated Study	Yes
IND/IDE Protocol	Yes
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC20DDDS0941
Approval Date	2021-02-16
Institutional Review Board Name	Seoul St. Mary’s Hospital, The Catholic University of Korea Center
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Whan-Seok Choi
Title	Ph.D
Telephone	+82-2-2258-6285
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul
Contact Person for Public Queries
Name	Whan-Seok Choi
Title	Ph.D
Telephone	+82-2-2258-6285
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul
Contact Person for Updating Information
Name	Hong Young Jang
Title	PhD
Telephone	+82-41-529-4161
Affiliation	Ceragem
Address	10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Completed
Date of First Enrollment	2021-03-09 Actual
Target Number of Participant	106
Primary Completion Date	2021-08-12 , Actual
Study Completion Date	2021-11-09 , Actual
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2021-04-13 ,
Recruitment Status by Participating Study Site 2
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2021-04-09 ,
Recruitment Status by Participating Study Site 3
Name of Study	Presbyterian Medical Center
Recruitment Status	Completed
Date of First Enrollment	2021-03-09 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ceragem
Organization Type	Others
Project ID	CRG_MV4_P01

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ceragem
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this clinical trial is to verify superiority over the comparator CGM MB-1901C of the test device CGM MB-1901 in non-specific back pain patients. The subjects will be randomized to test device group or comparator group who are 40mm or more on the Visual Analog Scale (VAS) after a screening period within two weeks. After subjects are randomized of this study, subjects apply test device or comparator over three weeks to verify the superiority of the test device CGM MB-1901 by comparing the Visual Analog Scale (VAS) changes.

Study Summary Information

Lay Summary

The purpose of this clinical trial is to verify superiority over the comparator CGM MB-1901C of the test device CGM MB-1901 in non-specific back pain patients.
The subjects will be randomized to test device group or comparator group who are 40mm or more on the Visual Analog Scale (VAS) after a screening period within two weeks. After subjects are randomized of this study, subjects apply test device or comparator over three weeks to verify the superiority of the test device CGM MB-1901 by comparing the Visual Analog Scale (VAS) changes.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	Apply 10 times for 3 Weeks to CGM MB-1901 or CGM MB-1901C.
Number of Arms	2
Arm 1	Arm Label CGM MB-1901
	Target Number of Participant 53
	Arm Type Experimental
	Arm Description Apply 10 times for 3 Weeks to CGM MB-1901.
Arm 2	Arm Label CGM MB-1901C
	Target Number of Participant 53
	Arm Type Sham comparator
	Arm Description Apply 10 times for 3 Weeks to CGM MB-1901C.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	(M00-M99)Diseases of the musculoskeletal system and connective tissue Non-specific low back pain
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description 1) Subjects who voluntarily consented, after listing enough explanation for this study and investigational device. 2) The following low back pain patients. (1) Over 40mm of VAS(Visual Analog Scale) (2) Chronic(last over 12 weeks) non-specific low back pain 3) Body mass index(BMI) over 18.5 and under 30
Exclusion Criteria	1) inflammatory spondylitis(spondylitis ankylopoietica, Other auto-disease spondylitis, infections etc.) 2) Scoliosis with Cobb angle> 30° 3) Under -2.5 SD of Osteoporosis 4) Spine fracture, serious trauma, operation in 6 months from Screening Visit 5) A systemic pain disorder : Fibromyalgia, depression etc. 6) Over 20 Score at Beck Depression Inventory II 7) Spondylosyndesis, artificial disc replacement or metallic implant patient at apply part of investigational device 8) Local aneurysm of plan for apply part of investigational device 9) skin excoriation, open wound, wound, scar of plan for apply part of investigational device 10) Subject who has plan to major surgery or surgery which barrier to judge for evaluate low back pain and apply investigational device
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	The value change of 100mm Visual Analog Scale(VAS) in EOT(End of Treatment) relative to the baseline
Timepoint	After apply Investigational device in Visit 11
Secondary Outcome(s) 1
Outcome	The value change of 100mm Visual Analog Scale(VAS) in each evaluation time(1st evaluate visit and 2nd evaluate visit) relative to the baseline
Timepoint	After apply Investigational device in Visit 5, Visit 8
Secondary Outcome(s) 2
Outcome	The fraction of improved subjects over 20% in each evaluation time(1st evaluate visit and 2nd evaluate visit, End of Treatment) relative to the baseline
Timepoint	After apply Investigational device in Visit 5, Visit 8, Visit 11

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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