![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/06/12 |
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 |
|
Condition | ||
Condition | Central airway stenosis due to intraluminal tumor, which caused dyspnea, hypoxemia, strider and requiring treatment | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |