UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029562 |
|---|---|
| Receipt number | R000033776 |
| Scientific Title | Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2021/12/03 19:11:39 |
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Basic information
Public title
Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Acronym
Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Scientific Title
Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Scientific Title:Acronym
Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine and evaluate the safety and performance of applying the endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi in patients undergoing pulmonary resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of bronchopleural fistula events within one month after pulmonary resection.
Key secondary outcomes
Incidence of postoperative complications
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
During surgical procedure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients likely to undergo segmental resection (2 segments or less) or middle lobe resection using Powered ECHELON FLEX 7
2) Age 20 years or older
3) Performance status 0 or 1 (ECOG classification)
4) Sufficient function of major organs
5) Written informed consent for participation in the study
Key exclusion criteria
1) Patients likely to undergo 3 segmental resections all together, such as basal segmentectomy. Patients likely to undergo 3 segmental resections whose bronchus would be resected separately are not excluded.
2) Active bacterial and/or fungal infection
3) Continuous use of systemic steroids
4) Uncontrolled diabetes mellitus
5) Investigator judgement that participation in the study would be difficult due to mental disorders/symptoms
6) Previous thoracic radiotherapy/chemotherapy within the past year
7) Judgement by the surgeon in charge that the patient is not suitable for participation
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Morihito |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima University Hospital
Division name
Surgical Oncology
Zip code
7340037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037
TEL
082-257-5869
morihito1217@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Miyata |
Organization
Hiroshima University Hospital
Division name
Surgical Oncology
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037
TEL
082-257-5869
Homepage URL
http://home.hiroshima-u.ac.jp/genge/
ymiyata@hiroshima-u.ac.jp
Sponsor or person
Institute
Surgical oncology, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital
Institute
Department
Personal name
Funding Source
Organization
Surgical oncology, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital
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
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 16 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033776
