UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050871 |
|---|---|
| Receipt number | R000057975 |
| Scientific Title | Safety and efficacy of robot-assisted gastric and colorectal surgery using Saroa Surgical System for malignant tumors. |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/04/17 20:33:05 |
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Basic information
Public title
Sugical study using Saroa Surgical System.
Acronym
Saroa Surgical System study
Scientific Title
Safety and efficacy of robot-assisted gastric and colorectal surgery using Saroa Surgical System for malignant tumors.
Scientific Title:Acronym
Saroa Surgical System study
Region
| Japan |
Condition
Condition
gastric and colorectal malignant tumors
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the safety and efficacy of the Saroa Surgical System in robot-assisted gastric and colorectal surgery for malignant tumors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
open conversion rate
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient is capable of radical resection.
PS (ECOG) is 0 or 1.
Informed consent has been obtained.
Key exclusion criteria
Patients who have undergone abdominal surgery for other diseases before and are expected to have a high degree of adhesion.
The doctor judges that it is inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastrointestinal Surgery,
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5254
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Tanioka |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5254
Homepage URL
tanioka.srg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Ethics Review Board, Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
| 2023 | Year | 05 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational items are the following;
Patient background (sex, age, height, weight, and comorbidities), surgical details (surgical technique, operation time, blood loss, anesthesia record), hospitalization records, pathological diagnosis, records after discharge (additional treatment and course, long-term complications), date of a hospital visit, and cause of death (only for those who died).
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057975
