UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020353 |
|---|---|
| Receipt number | R000023515 |
| Scientific Title | Intraoperative evaluation of free flap blood flow during head and neck reconstruction surgery using indocyanine green near infrared angiography |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2016/05/23 14:46:53 |
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Basic information
Public title
Intraoperative evaluation of free flap blood flow during head and neck reconstruction surgery using indocyanine green near infrared angiography
Acronym
Intraoperative evaluation of free flap blood flow during surgery using indocyanine green near infrared angiography
Scientific Title
Intraoperative evaluation of free flap blood flow during head and neck reconstruction surgery using indocyanine green near infrared angiography
Scientific Title:Acronym
Intraoperative evaluation of free flap blood flow during surgery using indocyanine green near infrared angiography
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate flap blood flow during head and neck reconstruction surgery using indocyanine green near infrared angiography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To confirm whole flap blood flow using indocyanine green near infrared angiography
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
0.1-0.3 mg/kg of indocyanine green at concentration of 5mg/mL is intravenously injected during head and neck reconstructive 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received head and neck reconstruction surgery with written informed consent
Key exclusion criteria
Patients who have allergy against indocyanine green or iodine, or who are (may be) pregnant, or whom a doctor considered not eligible
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Murono |
Organization
Kanazawa University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2413
murono@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Murono |
Organization
Kanazawa University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2413
Homepage URL
murono@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Otolaryngology-Head and Neck Surgery, Kanazawa University
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
| 2015 | Year | 12 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 04 | 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
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2016 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023515
