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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033721
Receipt No. R000038453
Scientific Title Safety evaluation and therapeutic effect analysis of knee hyperthermia with resonant cavity applicator
Date of disclosure of the study information 2018/08/11
Last modified on 2019/02/10

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Basic information
Public title Safety evaluation and therapeutic effect analysis of knee hyperthermia with resonant cavity applicator
Acronym Analysis of knee hyperthermia with resonant cavity applicator
Scientific Title Safety evaluation and therapeutic effect analysis of knee hyperthermia with resonant cavity applicator
Scientific Title:Acronym Analysis of knee hyperthermia with resonant cavity applicator
Region
Japan

Condition
Condition osteoarthritis of the knee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To perform thermal therapy using a resonant cavity applicator for healthy knee and osteoarthritis of the knee (knee OA), and to confirm safety and to analyze influence on clinical symptoms
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) in 6 months from treatment start
Key secondary outcomes Improvement of MRI T2 value of articular cartilage at 6 months from the start of treatment.
Confirmation that no adverse event occurs.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 20-40 W 20 min thermal therapy once every 1 to 4 weeks 10 times in total 6 months or less
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Osteoarthritis of the knee, KL grade 2-4
Key exclusion criteria Pregnant
Cases who can not enforce MRI examination
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kenji Takahashi
Organization International University of Health and Welfare Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 537-3 Iguchi, Nasushiobara, Tochigi,329-2763, Japan
TEL +81-287-39-3060
Email t-kenji@iuhw.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kenji Takahashi
Organization International University of Health and Welfare Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 537-3 Iguchi, Nasushiobara, Tochigi,329-2763, Japan
TEL +81-287-39-3060
Homepage URL
Email t-kenji@iuhw.ac.jp

Sponsor
Institute nternational University of Health and Welfare
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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
Address
Tel
Email

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
2018 Year 08 Month 11 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 04 Month 30 Day
Date trial data considered complete
2019 Year 05 Month 10 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 11 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038453

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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