UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031108 |
|---|---|
| Receipt number | R000035527 |
| Scientific Title | Clinical study: bronchoscopic lung mapping utilizing microcoil to assist esection of small lung tumors, a single-arm non-blinded uncontrolled study |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/02/25 12:55:07 |
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Basic information
Public title
Clinical study: bronchoscopic lung mapping utilizing microcoil to assist esection
of small lung tumors, a single-arm non-blinded uncontrolled study
Acronym
Bronchoscopic lung mapping utilizing microcoil to assist esection
of small lung tumors, a single-arm non-blinded uncontrolled study
Scientific Title
Clinical study: bronchoscopic lung mapping utilizing microcoil to assist esection
of small lung tumors, a single-arm non-blinded uncontrolled study
Scientific Title:Acronym
Bronchoscopic lung mapping utilizing microcoil to assist esection
of small lung tumors, a single-arm non-blinded uncontrolled study
Region
| Japan |
Condition
Condition
malignant tumor of the lung
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of the new method of virtual-assisted lung mapping utilizing microcoil as well as conventional dye marking
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
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
To place one or multiple microcoil in combinatin with multiple (3-6) dye marking of conventional VAL-MAP
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
1. Malignant pulmonary tumor (suspected or confirmed) that necessitates resection lines other tan usual interlobar fissure
2. In addition to conventional criteria for VAL-MAP, there is anticipated advantage in using microcoil such as
- Wedge resection is applied and the deep resection line is deeper than the outer 1/3 of the lung in CT, although the center of the tumor is in the outer 1/3,
- the center of the tumor is within the outer 1/3 of the lung
- high ldegree of pigmentation of the lung is anticipated
Key exclusion criteria
1. Allergic to platinum
2. Allergic to indigo carmine
3. For some reason, intra-airway placement of the microcil is difficult
4. pregnant woman
5. younger than 20 or patients whose own willness cannot be confirmed
6. Bronchschopy and/or marking procedure is not feasible due to complications
7. Anatomy precludes successful resection defined in this study
8. Other reasons a participating surgeon/physician judges the patient is not appropriate candidate for the study
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Sato |
| Middle name | |
| Last name | Masaaki |
Organization
The University of Tokyo Hospital
Division name
Thoracic Surgery
Zip code
1338655
Address
7-3-1 Hongo Bunkyoku
TEL
03-3815-5411
satom-sur@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Sato |
Organization
University of Tokyo Hospital
Division name
Thoracic Surgery
Zip code
113-8655
Address
7-3-1 Hongo Bunkyoku, Tokyo
TEL
03-3815-5411
Homepage URL
satom-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1 Hongo Bunkyoku
Tel
0338155411
satom-sur@h.u-tokyo.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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://cts.m.u-tokyo.ac.jp/column/val-map/
Number of participants that the trial has enrolled
6
Results
The study has been completed with excellent outcomes
Results date posted
| 2021 | Year | 02 | Month | 25 | Day |
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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035527
