UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047986 |
|---|---|
| Receipt number | R000054706 |
| Scientific Title | Verification of the safety and usefulness of the ultra-compact wide-field camera system (BirdView) during robot-assisted laparoscopic surgery |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2022/06/08 12:58:00 |
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Basic information
Public title
Verification of the safety and usefulness of the ultra-compact wide-field camera system (BirdView) during robot-assisted laparoscopic surgery
Acronym
Verification of the safety and usefulness of the ultra-compact wide-field camera system (BirdView) during robot-assisted laparoscopic surgery
Scientific Title
Verification of the safety and usefulness of the ultra-compact wide-field camera system (BirdView) during robot-assisted laparoscopic surgery
Scientific Title:Acronym
Verification of the safety and usefulness of the ultra-compact wide-field camera system (BirdView) during robot-assisted laparoscopic surgery
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of the safety and usefulness of the ultra-compact wide-field camera system (BirdView) during robot-assisted laparoscopic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety and usefulness
Key secondary outcomes
operation time and blood loss
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Implant a wide-field camera.
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
Patients scheduled for robot-assisted rectal resection at the Department of Gastrointestinal Oncology, Ehime University Hospital. Patients must be at least 20 years of age at the time of consent to be eligible. Only patients who give their voluntary consent will be included in the study.
Key exclusion criteria
Cases in which consent is not obtained
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Egi |
Organization
Ehime university
Division name
Gastrointestinal Surgery and Surgical oncology
Zip code
791-0295
Address
Shitsukawa 454, Toon, Ehime
TEL
0899605975
ogi.yusuke.xx@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ogi |
Organization
Ehime university
Division name
Gastrointestinal Surgery and Surgical oncology
Zip code
791-0295
Address
Shitsukawa 454,Toon, Ehime
TEL
0899605975
Homepage URL
ogi.yusuke.xx@ehime-u.ac.jp
Sponsor or person
Institute
Ehime university
Institute
Department
Personal name
Funding Source
Organization
Ehime university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-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
| 2022 | Year | 06 | Month | 08 | 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
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054706
