UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010815
Receipt No. R000012660
Scientific Title Evaluation of efficacy and safety of robot-assisted laparoscopic partial nephrectomy using Da Vinci S surgical system
Date of disclosure of the study information 2013/05/27
Last modified on 2013/05/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of efficacy and safety of robot-assisted laparoscopic partial nephrectomy using Da Vinci S surgical system
Acronym Clinical evaluation of robot-assisted laparoscopic partial nephrectomy
Scientific Title Evaluation of efficacy and safety of robot-assisted laparoscopic partial nephrectomy using Da Vinci S surgical system
Scientific Title:Acronym Clinical evaluation of robot-assisted laparoscopic partial nephrectomy
Region
Japan

Condition
Condition Renal tumors
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and safety of robot-assisted laparoscopic partial nephrectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes operation time, peri-operative complication, renal ischemic time, postoperative renal function, oncological outcome
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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 laparoscopic surgery using DaVince S surgical system
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Renal tumors 4cm or less, 2) exophytic tumors larger than 4cm
Key exclusion criteria 1) Patients with pT3a or those with metastases to lymph nodes or distant organs, 2) patients suspected to have severe intraabdominal adhesion due to multiple previous surgery, 3) patients for whom the surgery is not indicated, 4) Patients who are not considered eligible for this trial by a trial administrator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Tanabe
Organization Tokyo Women's Medical University
Division name Urology
Zip code
Address 8-1 Kawada-sho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Women's Medical University
Division name Urology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Urology, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Department of Urology, Tokyo Women's Medical University
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
Email

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
2013 Year 05 Month 27 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
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 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
2013 Year 05 Month 27 Day
Last modified on
2013 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.