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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030492
Receipt No. R000034454
Scientific Title An open-label, uncontrolled study of ERB ECRYO 2 in tissue removal at the site of obstruction/stenosis
Date of disclosure of the study information 2018/01/19
Last modified on 2019/06/23

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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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 09 Day
Last follow-up date
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
2019 Year 06 Month 23 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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