UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027219
Receipt No. 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

* 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 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
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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031189

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.