UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034227
Receipt No. R000039018
Scientific Title Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Date of disclosure of the study information 2018/09/21
Last modified on 2019/09/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Acronym Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Scientific Title Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Scientific Title:Acronym Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation
Region
Japan

Condition
Condition lumbar disc herniation
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to evaluate the feasibility and safety of dMD-001 implantation in patients after lumbar disc herniation, as a primary endpoint. We will explore the performance secondarily.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes 1) Feasibility dMD-001 implantation
The feasibility is evaluated as the implant achievement rate. With regard to implantation of dMD-001, judgment is made based on the criteria before or in surgery, and it is judged that implantation of dMD-001 is completed with the surface of dMD-001 being completely gelled.
2) Safety
Adverse events occurred 24 weeks after implantation of dMD-001 are summarized as safety assessments. Safety is assessed with the incidence of adverse events that can not deny the relationship with dMD-001.
Key secondary outcomes 1) VAS
2) FFD
3) SLR test
4) Modified Schober's test
5) JOA score
6) SF-36
7) ODI
8) RDQ
9) JOABPEQ
10) MRI signal change
11) Evaluation of dMD-001 implantation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Participants will undergo the standard discectomy followed by Sodium Alginate solution injection. The Sodium Alginate solution (up to 2ml) will be placed into the intervertebral disc cavity using a syringe and 10ml of 0.1 mol/l CaCl2 solution will be applied to the surface of the Sodium Alginate solution to gelate the alginate. Five minutes after the application of CaCl2 solution, the surgical site will be irrigated with a full-dose of sterile clinical grade normal saline.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients with lumbar disc herniation to plan discectomy
(2) MRI evidence of intervertebral disc herniation corresponding to symptoms
(3) Unresponsive to 6 consecutive weeks of therapy or experiencing acute/uncontrolled leg pain (80 mm or more out of 100 mm with VAS)
(4) Candidate for a one-level lumbar discectomy procedure
(5) Persistent and predominant leg pain (40 mm or more out of 100 mm with VAS)
(6) Aged 20-50
(7) Informed consent is obtained after the sufficient explanation of this study
Key exclusion criteria (1) Previous surgery involving index lumbar level
(2) Prior or planned procedure to fuse the lumbar spine
(3) The posterior bending angle of the intervertebral disc is recognized in any of the anterior bending, middle, and posterior bending of the lumbar spine X-ray image
(4) Greater than grade I spondylolisthesis or retrolisthesis at affected level
(5) Cauda equina syndrome
(6) Acute local or systemic infection
(7) Active malignancy or other similar comorbidities
(8) Drug-dependent patients or alcohol dependence patients
(9) Patients suffering from mental illness
(10) Current fracture, tumour and/or deformity of the lumbar spine
(11) Currently breast-feeding, pregnant, pregnancy during the trial period, or cannot do a highly effective contraceptive method
(12) Other clinical trials within 4 weeks
(13) Presence of any implanted metal or other contraindication to MRI
(14) Diagnosed as positive for allergic reactions to sodium alginate by allergy test (prick test)
(15) Contraindicated for this study due to other reasons
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Sudo
Organization Hokkaido University Hospital
Division name department of orthopedic surgery
Zip code 060-8638
Address North-15, West-7, Kita-ku, Sapporo, Hokkaido
TEL 011-716-5936
Email hidekisudo@yahoo.co.jp

Public contact
Name of contact person
1st name Nozomi
Middle name
Last name Yokota
Organization Hokkaido University Hospital
Division name Clinical Research and Medical Innovation Center
Zip code 060-8638
Address North-14, West-5, Kita-ku, Sapporo, Hokkaido
TEL 011-706-7735
Homepage URL
Email nozomi.yokota@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital Institutional Review Board
Address North-14, West-5, Kita-ku, Sapporo, Hokkaido
Tel 011-706-7061
Email tiken@med.hokudai.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(北海道)、えにわ病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 05 Day
Date of IRB
2018 Year 08 Month 28 Day
Anticipated trial start date
2018 Year 09 Month 21 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 21 Day
Last modified on
2019 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039018

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.