UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020820 |
|---|---|
| Receipt number | R000024038 |
| Scientific Title | Clinical application of surgical navigation system using image-recognition technique |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2024/08/08 19:14:29 |
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Basic information
Public title
Clinical application of surgical navigation system using image-recognition technique
Acronym
Clinical application of surgical navigation system using image-recognition technique
Scientific Title
Clinical application of surgical navigation system using image-recognition technique
Scientific Title:Acronym
Clinical application of surgical navigation system using image-recognition technique
Region
| Japan |
Condition
Condition
lung cancer with chest wall invasion
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the accuracy of the distance between tumor and the surgical margin using intraoperative navigation system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of the distance between tumor and the surgical margin
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the field measurement device (ex vivo), we measure the distance between tumor and surgical margin
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 of lung cancer with chest wall invasion
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toyofumi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nagoya University School of Medicine
Division name
department of thoracic surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442375
shota197065@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Nakamura |
Organization
Nagoya university hospital
Division name
department of thoracic surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442375
Homepage URL
shota197065@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number 19K18209
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
0527442375
shota197065@med.nagoya-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
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000020820
Publication of results
Partially published
Result
URL related to results and publications
https://rctportal.niph.go.jp/s/detail/um?trial_id
Number of participants that the trial has enrolled
1400
Results
We have successfully applied a navigation system to clinical practice. This system virtually depicts the tumor location before preoperative induction therapy using clinical image data and displays it side-by-side with real images during surgery.
Results date posted
| 2024 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients preparing surgical treatment
Participant flow
Informed concents were obtained in the preoperative outpatients site
Adverse events
none
Outcome measures
It was depend on each projects
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024038
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/02/07 | 3_研究計画書（介入研究）_別記様式第２号の４ 研究計画書（臨床介入研究）_202409.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/02/07 | 症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/02/07 | 研究症例データ.doc |
Single case data URL
Value
https://center6.umin.ac.jp/ice/24038
