UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058525 |
|---|---|
| Receipt number | R000066781 |
| Scientific Title | Clinical outcomes and histological analysis of disc tissue from patients with lumbar disc herniation |
| Date of disclosure of the study information | 2025/07/19 |
| Last modified on | 2025/07/19 18:32:29 |
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Basic information
Public title
Pathological conditions and histology of lumber intervertebral disc herniation
Acronym
Pathological conditions and histology of lumber intervertebral disc herniation
Scientific Title
Clinical outcomes and histological analysis of disc tissue from patients with lumbar disc herniation
Scientific Title:Acronym
Clinical outcomes and histological analysis of disc tissue from patients with lumbar disc herniation
Region
| Japan |
Condition
Condition
Lumbar disc herniation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the correlation between histological analysis of disc tissue and clinical conditions in patients with lumbar disc herniation.
Basic objectives2
Others
Basic objectives -Others
Histological analysis of the disc tissue
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between histological analysis and clinical conditions in lumbar disc herniation.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lumbar disc herniation who have any one of the following characteristics (i) to (iii): (i) Patients with a high signal intensity zone (HIZ) who were candidates for surgery, (ii) patients without a HIZ who were candidates for surgery, and (iii) patients who were candidates for surgery because of the failure of treatment with condoliase.
Key exclusion criteria
Patients who do not meet any of the inclusion criteria (i) to (iii)
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Dezawa |
Organization
Dezawa Akira PED Clinic
Division name
Department of Orthopaedic Surgery
Zip code
214-0014
Address
2141 Noborito, Tama-ku, Kawasaki, Kanagawa
TEL
0570-666-963
adezawajp@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Dezawa |
Organization
Dezawa Akira PED Clinic
Division name
Department of Orthopaedic Surgery
Zip code
214-0014
Address
2141 Noborito, Tama-ku, Kawasaki, Kanagawa
TEL
0570-666-963
Homepage URL
adezawajp@gmail.com
Sponsor or person
Institute
Dezawa Akira PED Clinic
Institute
Department
Personal name
Funding Source
Organization
Seikagaku Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Dezawa Akira PED Clinic
Address
2141 Noborito, Tama-ku, Kawasaki, Kanagawa
Tel
0570-666-963
ped.noda@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-interventional and non-invasive medical research based on ethical guidelines
Management information
Registered date
| 2025 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066781
