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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048531
Receipt No. R000055201
Scientific Title Effectiveness and safety of tumor site marking with da Vinci compatible near-infrared fluorescent clips (NIRFC) in Robot assisted surgery
Date of disclosure of the study information 2022/08/01
Last modified on 2022/08/01

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Basic information
Public title Effectiveness and safety of tumor site marking with da Vinci compatible near-infrared fluorescent clips (NIRFC) in Robot assisted surgery
Acronym da Vinci compatible NIRFC
Scientific Title Effectiveness and safety of tumor site marking with da Vinci compatible near-infrared fluorescent clips (NIRFC) in Robot assisted surgery
Scientific Title:Acronym da Vinci compatible NIRFC
Region
Japan

Condition
Condition gastrointestinal tumor
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Confirming the usefulness and safety of position marking with fluorescent clips in robotic surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tumour location recognition rate
Key secondary outcomes complication rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with oesophagogastrorectal tumours operated on using daVinchi.
Key exclusion criteria Patients for whom the study was explained and consent was not obtained
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Suzuki
Organization International University of Health and Welfare Hospital
Division name Department of surgery
Zip code 329-2763
Address 537-3, Iguchi, Nasushiobara, Tochigi
TEL 0287-37-2221
Email yutaka@iuhw.ac.jp

Public contact
Name of contact person
1st name Junji
Middle name
Last name Takahashi
Organization International University of Health and Welfare Hospital
Division name Department of surgery
Zip code 329-2763
Address 537-3, Iguchi, Nasushiobara, Tochigi
TEL 0287-37-2221
Homepage URL
Email jtakahashi1127@gmail.com

Sponsor
Institute International University of Health and Welfare Hospital
Institute
Department

Funding Source
Organization self funding
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 International University of Health and Welfare Hospital
Address 537-3, Iguchi, Nasushiobara, Tochigi
Tel 0287372221
Email jtakahashi1127@gmail.com

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 08 Month 01 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
2021 Year 05 Month 01 Day
Date of IRB
2018 Year 04 Month 10 Day
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2023 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Endoscopic clip placement is performed by a surgeon with at least five years' experience within the same institution.
All daVinchi procedures are performed by the same surgeon, who is a senior gastrointestinal surgeon with experience in at least 100 daVinchi procedures.
Clip placement is performed during upper gastrointestinal endoscopy or colonoscopy using a daVinchi-compatible NIRFC.
The endoscopic date for clip placement is the day before the operation.
Intraoperative observation with daVinch Xi in fire fly mode.

Management information
Registered date
2022 Year 08 Month 01 Day
Last modified on
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055201

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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