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A prospective, single-arm, single-center investigator initiated trial to evaluate the efficacy and safety of 3D printed bone grafts using BGS-7 for surgical reconstruction of zygomatic bone defect

Status Approved

First Submitted Date

2017/04/11
Registered Date

2018/01/09
Last Updated Date

2017/12/26

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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	KCT0002655
Unique Protocol ID	3DB-1701
Public/Brief Title	3D printed bone grafts using BGS-7 for surgical reconstruction of zygomatic bone defect
Scientific Title	A prospective, single-arm, single-center investigator initiated trial to evaluate the efficacy and safety of 3D printed bone grafts using BGS-7 for surgical reconstruction of zygomatic bone defect
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol	Yes
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	1712-004-268
Approval Date	2017-04-06
Institutional Review Board Name	Chung-Ang University Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
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	Uilyong Lee
Title	Assistant Professor
Telephone	+82-2-6299-2875
Affiliation	Chung-Ang Univerisity Hospital
Address	102, Heukseok-ro, Dongjak-gu, Seoul, KOREA
Contact Person for Public Queries
Name	Uilyong Lee
Title	Assistant Professor
Telephone	+82-2-6299-2875
Affiliation	Chung-Ang Univerisity Hospital
Address	102, Heukseok-ro, Dongjak-gu, Seoul, KOREA
Contact Person for Updating Information
Name	Uilyong Lee
Title	Assistant Professor
Telephone	+82-2-6299-2875
Affiliation	Chung-Ang Univerisity Hospital
Address	102, Heukseok-ro, Dongjak-gu, Seoul, 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	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2017-04-26 Actual
Target Number of Participant	10
Primary Completion Date	2018-04-30 , Anticipated
Study Completion Date	2018-07-31 , Anticipated
Name of Study	Chung-Ang Univerisity Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2017-04-26 ,

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	CGBio
Organization Type	Pharmaceutical Company
Project ID	3DB-1701

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chung-Ang Univerisity Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	A prospective, single-arm, single-center, investigator initiated trial to evaluate the efficacy and safety of 3D printed bone grafts using BGS-7 for surgical reconstruction of zygomatic bone defect..

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	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Medical Device, /Procedure/Surgery
Intervention Description	- Test design - This clinical trial evaluates the safety and efficacy of patient-tailored artificial zygomatic bone fabricated by applying FDM (Fused Deposition Modeling) 3D printing process technology using bioceramics (BGS-7) to adults who need reconstruction with zygomatic bone defect This study was designed as a prospective, single-arm, single-center, and investigatior initiated clinical trial to be conducted for a total of 10 clinical trial subjects from one domestic institution. - Test Methods - 1. A patient who visits the outpatient department of Oral and Maxillofacial Surgery of Chung-Ang University Hospital and wants to reconstruct the zygomatic bone defect and needs reconstruction will be referred to this clinical trial. 2. If subjects voluntarily sign the agreement and satisfy all the selection / exclusion criteria through screening, he/she will be enrolled in this trial and will be given the registration number of the study subject. 3. All subjects enrolled in this study were admitted prior to surgery 1 day prior to surgery and received antibiotics immediately prior to surgery (eg, 750 mg injection) 3D-printing artificial zygomatic bone). However, the date of admission and discharge may be adjusted under the tester's judgment
Number of Arms	1
Arm 1	Arm Label Single Arm
	Target Number of Participant 10
	Arm Type Experimental
	Arm Description - Test design - This clinical trial evaluates the safety and efficacy of patient-tailored artificial zygomatic bone fabricated by applying FDM (Fused Deposition Modeling) 3D printing process technology using bioceramics (BGS-7) to adults who need reconstruction with zygomatic bone defect This study was designed as a prospective, single-arm, single-center, and investigatior initiated clinical trial to be conducted for a total of 10 clinical trial subjects from one domestic institution. - Test Methods - 1. A patient who visits the outpatient department of Oral and Maxillofacial Surgery of Chung-Ang University Hospital and wants to reconstruct the zygomatic bone defect and needs reconstruction will be referred to this clinical trial. 2. If subjects voluntarily sign the agreement and satisfy all the selection / exclusion criteria through screening, he/she will be enrolled in this trial and will be given the registration number of the study subject. 3. All subjects enrolled in this study were admitted prior to surgery 1 day prior to surgery and received antibiotics immediately prior to surgery (eg, 750 mg injection) 3D-printing artificial zygomatic bone). However, the date of admission and discharge may be adjusted under the tester's judgment

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M89.88)Other specified disorders of bone, other
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~74Year
	Description 1. Adults who are over 19 years old and under 75 years old and have grown cheekbones 2. Those who have definite cheekbones defect and need reconstruction and want reconstruction 3. For women of childbearing age, those who agree to be contraceptive during the period of clinical trial participation (six months or more after surgery) 4. Those who voluntarily agree to participate in clinical trials and are willing to comply with the protocol
Exclusion Criteria	1. Those with uncontrolled metabolic disorders (eg diabetes, osteomalacia, thyroid disease) 2. Those who are taking or taking medications that can affect bone metabolism ☞ Bisphosphonate, Recombinant human parathyroid hormone (rhPTH), Denosumab, etc. 3. Those with uncontrolled gingivitis, periodontitis, or dental caries 4. Persons with severe heart disease or severe liver dysfunction 5. Persons with infectious diseases at risk of recurrence 6. Those with blood diseases (leukemia, hemophilia, sepsis, etc.) 7. Those who can not stop steroids, antithrombotics, and anticoagulants before surgery 8. Those who can not stop systemic corticosteroids or anabolic steroids for 3 months after surgery 9. People with osteomalacia and Paget's disease 10. Persons who have received radiation therapy at the surgical site 11. Allergic to implants 12. syphilis, severe epilepsy patient 13. People with substance abuse or alcoholism 14. Smokers 15. Who is currently pregnant or who has a pregnancy plan during the clinical trial 16. If the examiner determines that participation in the clinical trial is inadequate because it may affect other, ethical, or clinical trial results
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	Bone union rate / success rate of zygomatic bone
Timepoint	6 months after the procedure
Secondary Outcome(s) 1
Outcome	Subject Satisfaction
Timepoint	6 months after the procedure

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

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	Not provided at time of Registration

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