UMIN-CTR Clinical Trial

Basic information
Public title	A single center prospective interventional study for the evaluation of super-selective bronchial artery coil embolization on exercise tolerability in patients with chronic hemoptysis
Acronym	Exercise tolerability study of ssBACE
Scientific Title	A single center prospective interventional study for the evaluation of super-selective bronchial artery coil embolization on exercise tolerability in patients with chronic hemoptysis
Scientific Title:Acronym	Exercise tolerability study of ssBACE
Region	Japan

Condition
Condition	Chronic hemoptysis
Classification by specialty	Pneumology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether elective de-novo ssBACE improve 6-min walk test at one-month after the ssBACE in patients with chronic hemoptysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in 6-min walk test (m) at one-month after the ssBACE as compared to the baseline value
Key secondary outcomes	Changes in the followings as compared to the baseline values - ABG findings - Post-procedural PO2, PCO2, HCO3-, A-aDO2, and pH - Spirometry findings - %VC and FEV1.0% at 1-month after ssBACE

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	De-novo elective ssBACE Six-min walk test (Preprocedural and at one-month) Arterial blood gas (Pre- and post-procedural) Spirometry (Preprocedural and at one-month)
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Chronic hemoptysis 2. Expected to undergo de-novo elective ssBACE 3. Written informed consent from the patient
Key exclusion criteria	1. Need for oxygenation during ssBACE 2. Difficulty to understand the study such as due to psychiatric disorder or dementia 3. Other reasons (at the attending physician's discretion)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Ishikawa
Organization	Eishinkai Kishiwada Rehabilitation Hospital
Division name	Hemoptysis and Pulmonary-Circulation Center
Zip code	596-0827
Address	Kanmatsu-cho 2-8-10, Kishiwada City, Osaka, Japan
TEL	072-426-7777
Email	h_ishikawa@eishinkaihsp.or.jp

Public contact
Name of contact person	1st name Masahiko Middle name Last name Hara
Organization	The Japan Society of Clinical Research
Division name	Department of Clinical Investigation
Zip code	530-0001
Address	Kita-ku Umeda 1-11-4-1000 Osaka Ekimae 4th Bldg 10F
TEL	06-6131-5495
Homepage URL
Email	hara@japanscr.org

Sponsor
Institute	Hemoptysis and Pulmonary-Circulation Center Eishinkai Kishiwada Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Hemoptysis and Pulmonary-Circulation Center Eishinkai Kishiwada Rehabilitation Hospital
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	IRB of Eishinkai Kishiwada Rehabilitation Hospital
Address	Kanmatsu-cho 2-8-10, Kishiwada City, Osaka, Japan
Tel	072-426-7777
Email	h@ishikawa.email.ne.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	2021 Year 09 Month 20 Day

Related information
URL releasing protocol	Not available
Publication of results	Unpublished

Result
URL related to results and publications	Not available
Number of participants that the trial has enrolled	113
Results	Results are expected to be published elsewhere (now under review).
Results date posted	2021 Year 09 Month 20 Day
Results Delayed	Delay expected
Results Delay Reason	Manuscript under review
Date of the first journal publication of results
Baseline Characteristics	Results are expected to be published elsewhere (now under review).
Participant flow	Results are expected to be published elsewhere (now under review).
Adverse events	Results are expected to be published elsewhere (now under review).
Outcome measures	Results are expected to be published elsewhere (now under review).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2015 Year 09 Month 10 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2020 Year 11 Month 04 Day
Date of closure to data entry	2021 Year 01 Month 08 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 09 Month 20 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051972