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

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 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

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

Value
https://center6.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