UMIN-CTR Clinical Trial

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
Email	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
Email	satom-sur@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035527