UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060933 |
|---|---|
| Receipt number | R000069731 |
| Scientific Title | A prospective study evaluating the feasibility and operability of i-Lung, a three-dimensional lung model intraoperative reference system in thoracoscopic lung resection. |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/03/13 21:00:45 |
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Basic information
Public title
A prospective study evaluating the feasibility and operability of i-Lung, a three-dimensional lung model intraoperative reference system in thoracoscopic lung resection.
Acronym
i-Lung for VATS study
Scientific Title
A prospective study evaluating the feasibility and operability of i-Lung, a three-dimensional lung model intraoperative reference system in thoracoscopic lung resection.
Scientific Title:Acronym
i-Lung for VATS study
Region
| Japan |
Condition
Condition
Diseases requiring thoracoscopic anatomical lung resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study prospectively evaluates the feasibility, operability, and safety of using the i-Lung 3D simulator for VATS during intraoperative surgery. It will verify the "ability to complete the operation" and the "contribution to the surgeon's anatomical understanding" when operating the system using a game controller within the sterile field during surgery. The evaluation will be conducted through questionnaires administered to surgeons and assistants who participated in the surgery and operated i-Lung.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anatomical agreement with the previously approved 3D workstation (VINCENT)
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
| Device,equipment |
Interventions/Control_1
During surgery, images from i-Lung are displayed on the operating room monitor, and the surgeon manipulates the model using a control device fitted with a sterile cover.
The i-Lung used in this study is an unapproved medical device that has not obtained manufacturing and marketing approval under the Pharmaceuticals and Medical Devices Act. This system is used for the purpose of presenting clinical support information during surgery; the final decisions regarding surgical procedure selection, vascular and bronchial treatment, etc., will be made by the surgeon based on conventional surgical field findings and existing image information.
Furthermore, if it is determined that the use of this system may affect the progress of the surgery, its use will be immediately discontinued and the normal surgical procedure will be continued.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 or older
Patients scheduled for thoracoscopic lung resection
Patients for whom written informed consent can be obtained
Key exclusion criteria
Patients who could not provide written consent
Patients deemed unsuitable by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kawakita |
Organization
Tokushima University Hospital
Division name
Thorcic surgery
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
0886313111
kawakita.naoya@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Noaya |
| Middle name | |
| Last name | Kawakita |
Organization
Tokushima University Hospital
Division name
Thoracic surgery
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
0886313111
Homepage URL
kawakita.naoya@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokushima University Hospital Comprehensive Clinical Research Center
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
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
| 2026 | Year | 03 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069731
