UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000063458
Receipt number	R000072630
Scientific Title	A prospective study on the feasibility of implementing the iLung intraoperative reference system based on 3D lung models for thoracoscopic and robotic assisted pulmonary segmentectomy A multicenter evaluation
Date of disclosure of the study information	2026/10/31
Last modified on	2026/10/29 13:14:24

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Basic information

Public title

A prospective study on the feasibility of implementing the iLung intraoperative reference system based on 3D lung models for thoracoscopic and robotic assisted pulmonary segmentectomy A multicenter evaluation

Acronym

A prospective study on the multi-center implementability of i-Lung

Scientific Title

Scientific Title:Acronym

A prospective study on the multi-center implementability of i-Lung

Region

Japan

Condition

Patients with pulmonary disease scheduled for thoracoscopic pulmonary segmentectomy

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To prospectively evaluate whether i-Lung, a research software that displays surgeon-defined patient-specific three-dimensional lung models with planned transection sites recorded as 3D cut rings, can be prepared and operated by local staff and used for intraoperative reference in addition to the conventional reference methods of each institution during thoracoscopic (VATS) or robot-assisted (RATS) pulmonary segmentectomy at Tokushima University Hospital and four collaborating hospitals (multicenter feasibility of implementation). The primary endpoint is the proportion of procedures in which intraoperative use was completed; operability, user acceptance, and system stability are also assessed.

Basic objectives2

Others

Basic objectives -Others

Feasibility of implementation (preparation, operation, and completion of intraoperative use across multiple institutions

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

intraoperative use, defined as procedures in which i-Lung was started and displayed intraoperatively and used until the end of surgery without system-related discontinuation (technical failure, system crash, or interruption of image display that made continued use impossible). Recovery after restart or reconnection with continued use is counted as completed use. Recorded by local staff on the case report form at the end of surgery.

Key secondary outcomes

Number of system-related interruptions of surgery
Preparation time (from start of STL export to completion of 3D cut-ring placement) and operating-room setup time (from start-up to completion of display)
Proportion of procedures in which case data preparation and operating-room setup were performed by local staff alone, and the content of support provided by the principal investigator
Surgeon questionnaire (anatomical concordance with existing 3D images, operability of the input device, usefulness of autonomous manipulation, support for spatial recognition, confidence in surgical decision-making, intention of future use: 5-point Likert scale; change in mental workload: 7-point scale)
Assistant questionnaire (understanding of the surgeon's intent, time saved in reaching shared understanding, convenience of sharing the input device, avoidance of surgical interruption, educational value: 5-point Likert scale; change in mental workload: 7-point scale)
Number of manipulations and total manipulation time per procedure based on automatically recorded operation logs
Surgical steps during which i-Lung was referenced
Plan execution rate (proportion of placed 3D cut rings at which transection was performed at the ring position), number transected at a different position, and number not transected
Number of structures transected without a cut ring, classified by whether the structure was depicted in the 3D image
Distribution of the above by approach (VATS/RATS) and by conventional intraoperative reference method System stability: incidence of system trouble (rendering delay, freeze, connection failure), system-related discontinuation and interruption of surgery, events related to sterile handling, and intraoperative events (conversion to thoracotomy, change of planned procedure, intraoperative vascular injury, bronchial injury, misidentified transection), all summarized descriptively

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

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

In addition to the conventional intraoperative 3D image reference methods of each institution (printed images, external monitor, tablet, etc.), the patient-specific 3D lung model is displayed intraoperatively with i-Lung (multicenter study stable version MC 1.0). Preoperatively, the patient-specific 3D model (STL format) created with the 3D image analysis software of each institution is imported into i-Lung, and the surgeon places 3D cut rings at the planned transection sites and saves the planning data. Intraoperatively, in VATS the model is displayed on the operating-room monitor and manipulated from the sterile field by the surgeon or assistant using a wireless game controller covered with a sterile transparent cover; in RATS it is displayed in the surgeon console via the external video input (TilePro) of the surgical robot and manipulated with a mouse in the non-sterile field. The frequency and timing of reference are at the discretion of the surgeon, and surgical technique, procedure, instruments, and anesthesia are not changed. Final decisions on procedure selection and vascular/bronchial transection are made by the surgeon based on conventional operative findings and existing imaging. i-Lung automatically records operation logs. Surgeons and assistants complete questionnaires on the day of surgery or the following day.

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

Age 18 years or older
Patients scheduled for pulmonary segmentectomy by VATS or RATS
Patients for whom a patient-specific 3D model (STL format) can be created from preoperative CT using the 3D image analysis software of the institution
Patients able to provide written informed consent

Key exclusion criteria

Patients who did not provide written informed consent
Patients judged inappropriate by the site principal investigator

Target sample size

Research contact person

Name of lead principal investigator

1st name Naoya

Middle name

Last name Kawakita

Organization

Tokushima University Hospital

Division name

Department of Thoracic Surgery

Zip code

770-8503

Address

3-18-15 Kuramoto-cho, Tokushima Japan

TEL

088-633-7136

Email

kawakita.naoya@tokushima-u.ac.jp

Public contact

Name of contact person

1st name Naoya

Middle name

Last name Kawakita

Organization

Tokushima University Hospital

Division name

Department of Thoracic Surgery

Zip code

770-8503

Address

3-18-15 Kuramoto-cho, Tokushima Japan

TEL

088-633-7136

Homepage URL

Email

kawakita.naoya@tokushima-u.ac.jp

Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name

Funding Source

Organization

Tokushima University FY2026 Clinical Drug Discovery and Medical Device PoC Program

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Tokushima Municipal Hospital; Tokushima Red Cross Hospital; Tokushima Prefectural Central Hospital; Kochi Red Cross Hospital

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Ethics Committee for Life Sciences and Medical Research, Tokushima University Hospita

Address

2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan

Tel

088-633-851

Email

first-ec@tokushima-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2026 Year 10 Month 31 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 10 Month 30 Day

Date of IRB

Anticipated trial start date

2027 Year 02 Month 01 Day

Last follow-up date

2029 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 10 Month 29 Day

Last modified on

2026 Year 10 Month 29 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072630