UMIN-CTR Clinical Trial

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
Email	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
Email	ogi.yusuke.xx@ehime-u.ac.jp

Sponsor
Institute	Ehime university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054706