UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006679 |
|---|---|
| Receipt number | R000007892 |
| Scientific Title | Identification of lung segmental surface using Photodynamic Eye (PDE) |
| Date of disclosure of the study information | 2011/11/07 |
| Last modified on | 2022/01/14 12:56:04 |
* 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
Identification of lung segmental surface using Photodynamic Eye (PDE)
Acronym
Identification of lung segmental surface using Photodynamic Eye (PDE)
Scientific Title
Identification of lung segmental surface using Photodynamic Eye (PDE)
Scientific Title:Acronym
Identification of lung segmental surface using Photodynamic Eye (PDE)
Region
| Japan |
Condition
Condition
Patients who pulmonary segmentectomy will be carried out.
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We inspect usefulness and safety of PDE in a lung segmentectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Is the identification of the segmental surface possibility?
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
Fluorescent imaging with a PDE.
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
Patients who pulmonary segmentectomy will be carried out.
Key exclusion criteria
COPD
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053-435-2276
kfunai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053-435-2276
Homepage URL
kfunai@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
| 2011 | Year | 11 | Month | 07 | 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
| 2010 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007892
