UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014660 |
|---|---|
| Receipt number | R000017054 |
| Scientific Title | A clinical study for evaluating the utility and safety of robot-assisted gynecologic surgery using da Vinci Si surgical system |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2017/01/26 09:14:27 |
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Basic information
Public title
A clinical study for evaluating the utility and safety of robot-assisted gynecologic surgery using da Vinci Si surgical system
Acronym
A clinical study for evaluating the utility and safety of robot-assisted gynecologic surgery
Scientific Title
A clinical study for evaluating the utility and safety of robot-assisted gynecologic surgery using da Vinci Si surgical system
Scientific Title:Acronym
A clinical study for evaluating the utility and safety of robot-assisted gynecologic surgery
Region
| Japan |
Condition
Condition
cervical cancer, endometrial cancer, atypical endometrial hyperplasia, uterine myoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility and safety of robot-assisted surgery for gynecologic malignancies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Anesthesia time, operative time, blood loss, intraoperative and postoperative complications, postoperative pain and hospital stay
Key secondary outcomes
Number of removed lymph nodes, postoperative levels of hemoglobin (Hb), white blood cells (WBC) and C-ractive proteins (CRP), and fever
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robot-assisted surgery for gynecologic malignancies
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Atypical endometrial hyperplasia
Endometrial cancer FIGO stage IA
Cervical cancer FIGO stage IA1-IIB
Key exclusion criteria
Patients who are not recommended for laparoscopic surgery or study enrollment because of complications and other factors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyomi Satoh |
Organization
University of Tsukuba
Division name
Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3049
toyomi-s@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ochi |
Organization
University of Tsukuba
Division name
Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3073
Homepage URL
hochi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
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
Address
Tel
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
筑波大学附属病院 (茨城県)
Other administrative information
Date of disclosure of the study information
| 2014 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 26 | Day |
Last modified on
| 2017 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017054
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
