UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)
Title of the study (Brief title)	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	Taku Yasumoto
Organization	Miyakojima IGRT clinic
Division name	Department of Interventional Radiology
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	Taku Yasumoto
Organization	Miyakojima IGRT clinic
Division name	Department of Interventional Radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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