UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040908 |
|---|---|
| Receipt number | R000043979 |
| Scientific Title | safety study of trans oral robotic surgery using DaVinci surgical system in Otolaryngology. |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2020/06/26 01:24:53 |
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Basic information
Public title
safety study of robotic surgery using DaVinci surgical system in Otolaryngology
Acronym
safety study of trans oral robotic surgery
Scientific Title
safety study of trans oral robotic surgery using DaVinci surgical system in Otolaryngology.
Scientific Title:Acronym
safety study of trans oral robotic surgery using DaVinci surgical system
Region
| Japan |
Condition
Condition
Resectable T1/T2 oropharyngeal cancer or supraglottic cancer or benign tumor in oropharynx or larynx
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety evaluation of trans oral robotic surgery(TORS)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operation time, intra-operative bleeding, Postoperative complication, length of hospital stay
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
trans oral surgery with DaVinci 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Resectable T1/T2 oropharyngeal cancer or supraglottic cancer or benign tumor in oropharynx or larynx.
1) under 20 years old
2) respectable case from February 1, 2019 to March 31, 2021 at Nagoya university hospital
3) No history of radiation therapy
4) No history of chemotherapy or radiation therapy for head and neck cancer except for tongue cancer
5) No history of chemotherapy or radiation therapy for other cancer
6) No simultaneous or metachronism head and neck cancer
Key exclusion criteria
1) Minor
2) Infectious diseases needed systemic treatment
3) simultaneous or metachronism cancer
4) Fever over 38 degrees
5) pregnant or may be pregnant
6) depression or psychosis
7) unstable angina
8) caa not obtain consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Fujimoto |
Organization
Nagoya university hospital
Division name
Otolaryngology
Zip code
466-8560
Address
tsurumai 65 shouwa nagoya city, aichi, japan
TEL
052-744-2323
tmaruo@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | takashi |
| Middle name | |
| Last name | Maruo |
Organization
nagoya university hospital
Division name
Otolaryngology
Zip code
466-8560
Address
tsurumai 65 shouwa nagoya city, aichi, japan
TEL
052-744-2323
Homepage URL
tmaruo@med.nagoya-u.ac.jp
Sponsor or person
Institute
nagoya university
Institute
Department
Personal name
Funding Source
Organization
nagoya 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
IRB nagoya university
Address
tsurumai 65 shouwa nagoya city, aichi, japan
Tel
052-744-2323
tmaruo@med.nagoya-u.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
| 2026 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043979
