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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024385
Receipt No. R000028072
Scientific Title Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)
Date of disclosure of the study information 2016/10/13
Last modified on 2018/05/08

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Basic information
Public title Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)
Acronym TAME: JMIS-1604 (INSTEP study)
Scientific Title Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)
Scientific Title:Acronym TAME: JMIS-1604 (INSTEP study)
Region
Japan

Condition
Condition Chronic pain from tendinopathy and enthesopathy refractory to non-surgical management
Classification by specialty
Orthopedics Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1)Numerical Rating Scale (NRS) in 6 months after procedure
2)lateral epicondylitis or medial epiconylitis: Quick Disablities of the Arm, Shoulder and Hand (DASH) score in 6 months after the procedure,
Patella tendinitis: Victorian Institute of Sport Assessment (VISA) score in 6 months after the procedure,
Achilles tendinitis or plantar fasciitis: Foot & Ankle Disability Index (FADI) score in 6 months after the procedure
3)Quality of life(QOL) in 6 months after the procedure
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Transcatheter arterial micro embolization: TAME
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
12 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1.Previous conservative therapies applied for at least 3 months and persistent moderate-to-severe hip pain (NRS>=5).
2.Lateral epicondylitis, medial epicondylitis, patella tendinitis, Achilles tendinitis, or plantar fasciitis is clinically diagnosed or suspected.
3.Patients with maintain major organ (bone marrow, heart, liver, lung, kidney) function.
4.Patients with possibility of going to hospital and follow up for 6 months.
5.Provided written informed consent to undergo the procedure.
Key exclusion criteria 1.Surgical candidate
2.Patients with severe infection, rheumatoid arthritis, or mental disorder
3.Patients with uncontrollable diabetic mellitus
4.Pain due to spine pathology
5.Patients with osteonecrosis with magnetic resonance imaging (MRI)
6.Patients without possibility of going to hospital and follow up for 6 months.
7.Patient who was decided not to be appropriate for this trial by physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Yasumoto
Organization Miyakojima IGRT clinic
Division name Department of Interventional Radiology
Zip code
Address 1-16-22 Miyakojima Hondori, Miyakojima-ku, Osaka, 534-0021, JAPAN
TEL 06-6923-3501
Email yasumoto@solid.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Yasumoto
Organization Miyakojima IGRT clinic
Division name Department of Interventional Radiology
Zip code
Address 1-16-22 Miyakojima Hondori, Miyakojima-ku, Osaka, 534-0021, JAPAN
TEL 06-6923-3501
Homepage URL
Email yasumoto@solid.ocn.ne.jp

Sponsor
Institute Miyakojima IGRT clinic
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 都島放射線科クリニック(大阪府)
社会福祉法人仁生社 江戸川病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 13 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 Completed
Date of protocol fixation
2016 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 13 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028072

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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