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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023755
Receipt No. R000027375
Scientific Title Visual assessment of blood flow in the rotator cuff and labrum.
Date of disclosure of the study information 2016/08/25
Last modified on 2017/06/20

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Basic information
Public title Visual assessment of blood flow in the rotator cuff and labrum.
Acronym Visual assessment of blood flow in the rotator cuff and labrum.
Scientific Title Visual assessment of blood flow in the rotator cuff and labrum.
Scientific Title:Acronym Visual assessment of blood flow in the rotator cuff and labrum.
Region
Japan

Condition
Condition Rotator cuff tears,glenoid labrum tears
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to carry out a visual assessment of the blood flow of the labrum and rotator cuff.
Basic objectives2 Others
Basic objectives -Others We investigate the association of muscle atrophy and blood flow.
We investigate the relationship between size and blood flow in the rotator cuff tear.
We investigate the relationship between glenoid labrum tear and blood flow.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Using indocyanine green during surgery, perform a visual evaluation of the rotator cuff and glenoid labrum.
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 We do the intravenous administration of indocyanine Goon in blood flow evaluation purposes during surgery.
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
0 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria We do prospective studies in patients to perform under direct vision surgery or shoulder arthroscopy at our institution.
Key exclusion criteria 1:Patients with a history of hypersensitivity to components of the ICG
2:Patients with a history of iodine hypersensitivity
3:Patients who did not agree to participate in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobunao Doi
Organization Fukuoka University Hospital
Division name Orthopedics
Zip code
Address 814-0180,7-45-1, Nanakuma, Jonan-ku,Fukuoka-shi,Fukuoka
TEL 092-801-1011
Email doi03121028@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobunao Doi
Organization Fukuoka University Hospital
Division name Orthopedics
Zip code
Address 814-0180,7-45-1, Nanakuma, Jonan-ku,Fukuoka-shi,Fukuoka
TEL 092-801-1011
Homepage URL
Email doi03121028@gmail.com

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Fukuoka University Hospital
Organization
Division
Category of Funding Organization Other
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
2016 Year 08 Month 25 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 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 08 Month 25 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027375

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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