UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059896 |
|---|---|
| Receipt number | R000068500 |
| Scientific Title | A prospective observational study to evaluate the safety of robot-assisted gastrectomy using the da Vinci SP |
| Date of disclosure of the study information | 2025/11/26 |
| Last modified on | 2025/11/26 22:30:00 |
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Basic information
Public title
A prospective observational study to evaluate the safety of robot-assisted gastrectomy using the da Vinci SP
Acronym
An observational study of robot-assisted gastrectomy using the da Vinci SP
Scientific Title
A prospective observational study to evaluate the safety of robot-assisted gastrectomy using the da Vinci SP
Scientific Title:Acronym
An observational study of robot-assisted gastrectomy using the da Vinci SP
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of robotic-assisted gastrectomy using the da Vinci SP for gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate of robotic-assisted gastrectomy using da Vinci SP
Key secondary outcomes
Surgical complication rate, blood loss, surgical time, post-discharge complications and recurrence
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Gastric cancer patients who are eligible for robotic-assisted gastrectomy using a da Vinci SP based on preoperative examination.
2) Patients who are willing to follow the research protocol.
3) Patients have signed a consent form for participation in the study that has been approved by our institution's ethical review board. However, a proxy may sign only if the patient is unable to sign due to a physical disability.
Key exclusion criteria
1) Women who may be pregnant or who are breastfeeding.
2) Patients with psychiatric illness or symptoms who are deemed to make it difficult to participate in the study.
3) Patients who are deemed to be inappropriate for endoscopic surgery.
4) Patients with serious medical conditions that the principal investigator or co-researcher deems inappropriate for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Omori |
Organization
Osaka Keisatsu Hospital
Division name
Department of Gastroenterological Surgery
Zip code
543-8922
Address
2-6-40, Karasugatuji, Tennnouji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
omori.takeshi05@oim.or.jp
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Nakahara |
Organization
Osaka Keisatsu Hospital
Division name
Department of Gastroenterological Surgery
Zip code
543-8922
Address
2-6-40, Karasugatuji, Tennnouji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
Homepage URL
nakahara.yujiro75@oim.or.jp
Sponsor or person
Institute
Osaka Keisatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Osaka Keisatu Hospital, Ethics committee
Address
2-6-40, Karasugatuji, Tennnouji-ku, Osaka 543-8922, Japan
Tel
06-6771-6051
shomu@oph.gr.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
| 2025 | Year | 11 | Month | 26 | 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
| 2025 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2005 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For the first two years after surgery, follow-up examinations to check for recurrence should be conducted at least every six months. After that, they should be done at least once a year until five years post-surgery, with ongoing monitoring.
Management information
Registered date
| 2025 | Year | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068500
