UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016244 |
|---|---|
| Receipt number | R000018851 |
| Scientific Title | Intraoperative identification of the interlobar/intersegmental plane by thoracoscopic fluorescence imaging system in lung resection |
| Date of disclosure of the study information | 2015/01/19 |
| Last modified on | 2018/07/22 14:36:53 |
* 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
Intraoperative identification of the interlobar/intersegmental plane by thoracoscopic fluorescence imaging system in lung resection
Acronym
Intraoperative identification of the interlobar/intersegmental plane by thoracoscopic fluorescence imaging system in lung resection
Scientific Title
Intraoperative identification of the interlobar/intersegmental plane by thoracoscopic fluorescence imaging system in lung resection
Scientific Title:Acronym
Intraoperative identification of the interlobar/intersegmental plane by thoracoscopic fluorescence imaging system in lung resection
Region
| Japan |
Condition
Condition
Respiratory disease
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether the thoracoscopic fluorescence imaging system using the indocyanine green could identify the interlobar/intersegmental plane in lung resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
identification of the interlobar/intersegmental plane
Key secondary outcomes
hospitalization/operative time/amount of bleeding/air leakage(duration)/duration of the chest drainage/adverse events in the perioperative period
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
indocyanine green
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients maintaining the functions of the main organs.
2.A case that an operation under the general anesthesia is possible.
3.A case that a document agrrement by the examination participation.
Key exclusion criteria
1.Pregnant or potentially women, nursing women
2.Past history of the open thoracotomy
3.Patients with psychiatric diseases
4.Patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Hanaoka |
Organization
Shiga University of Medical Science
Division name
Department of thoracic surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2244
hanaoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Hanaoka |
Organization
Shiga University of Medical Science
Division name
Department of thoracic surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2244
Homepage URL
hanaoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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)
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 | 01 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 19 | 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 | 01 | Month | 17 | Day |
Last modified on
| 2018 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018851
