UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023755 |
|---|---|
| Receipt number | 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 | 2021/03/04 13:16:41 |
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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
| 18 | 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
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
doi03121028@gmail.com
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
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
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
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027375
