UMIN-CTR Clinical Trial

Basic information
Public title	An open-label, uncontrolled study of ERB ECRYO 2 in tissue removal at the site of obstruction/stenosis
Acronym	J-CRYO 2
Scientific Title	An open-label, uncontrolled study of ERB ECRYO 2 in tissue removal at the site of obstruction/stenosis
Scientific Title:Acronym	J-CRYO 2
Region	Japan

Condition
Condition	Central airway stenosis due to intraluminal tumor, which caused dyspnea, hypoxemia, strider and requiring treatment
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of ERBE CRYO2 (a general-purpose cryosurgery unit) in tissue removal at the site of obstruction/stenosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Moderate or severe intraoperative bleeding
Key secondary outcomes	Rate of procedural success. Incidence of adverse events. Percentage of subjects with intraoperative SpO 2 of 95% or less.

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	ERBE CRYO2 (a general-purpose cryosurgery unit) will be used in tissue removal at the site of obstruction/stenosis
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients with central airway stenosis due to intraluminal tumor which requires treatment for symptoms, such as dyspnea, hypoxemia, or strider (2) Those who can tolerate bronchoscopy (3) Written consent from the patient or representatives
Key exclusion criteria	(1) Unstable angina, or myocardial infarction within 6 months (2) Marked bleeding tendency such as anticoagulant in use (3) AST/ALT >= 100 IU/L (4) Pregnant or possibly pregnant (5) Deemed unsuitable to participate in this study by the principal investigator (PI)/sub-investigators
Target sample size	30

Research contact person
Name of lead principal investigator	1st name HIDEO Middle name Last name SAKA
Organization	National Hospital Organization Nagoya Medical Center
Division name	Respiratory Medicine
Zip code	460-0001
Address	Naka-Ku
TEL	052-951-1111
Email	saka@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name HIDEO Middle name Last name SAKA
Organization	Nagoya Medical Center
Division name	Respiratory Medicine
Zip code	460-0001
Address	Naka-Ku
TEL	052-951-1111
Homepage URL	https://www.nnh.go.jp/
Email	saka@med.nagoya-u.ac.jp

Sponsor
Institute	National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Nagoya Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Nagoya Medical Center
Address	4-1-1 Sannomaru, Naka-Ku
Tel	0529511111
Email	yonejima.tadashi.ab@mail.hosp.go.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	独立行政法人　国立病院機構 名古屋医療センター（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6754988/
Number of participants that the trial has enrolled	28
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	Completed
Date of protocol fixation	2018 Year 02 Month 09 Day
Date of IRB	2018 Year 02 Month 09 Day
Anticipated trial start date	2018 Year 02 Month 09 Day
Last follow-up date	2020 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 20 Day
Last modified on	2020 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034454

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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