UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027219 |
|---|---|
| Receipt number | R000031189 |
| Scientific Title | Phase II trial of Transcatheter arterial micro-embolization for refractory chronic hip pain: Multicenter Study (REACH study) |
| Date of disclosure of the study information | 2017/05/02 |
| Last modified on | 2018/05/08 10:20:21 |
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Basic information
Public title
Phase II trial of Transcatheter arterial micro-embolization for refractory chronic hip pain: Multicenter Study (REACH study)
Acronym
hip TAME: JMIS-1603 (REACH study)
Scientific Title
Phase II trial of Transcatheter arterial micro-embolization for refractory chronic hip pain: Multicenter Study (REACH study)
Scientific Title:Acronym
hip TAME: JMIS-1603 (REACH study)
Region
| Japan |
Condition
Condition
Chronic hip pain refractory to non-surgical management due to mild osteoarthritis
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase II trial of Transcatheter arterial micro-embolization for refractory chronic hip pain: Multicenter Study (REACH study)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Numerical Rating Scale (NRS) in 6 months after procedure
Oxford Hip score in 6 months after procedure
Quality of Life(QOL) in 6 months after 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
| 20 | 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.Chronic hip pain with mild osteoarthritis (Kellgren-Lawrence grading system 0-3)
3.Patients with no severe hip osteoarthritis (Kellgren-Lawrence grading system 4)
4.Patients with maintain major organ (bone marrow, heart, liver, lung, kidney) function.
5.Patients with possibility of going to hospital and follow up for 6 months.
6.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
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
yasumoto@solid.ocn.ne.jp
Sponsor or person
Institute
Miyakojima IGRT clinic
Institute
Department
Personal name
Funding Source
Organization
non
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
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
| 2017 | Year | 05 | Month | 02 | 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 | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 02 | 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
| 2017 | Year | 05 | Month | 02 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031189
