UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030492 |
|---|---|
| Receipt number | 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 | 2020/06/12 13:36:37 |
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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
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/
saka@med.nagoya-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034454
