UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024210 |
|---|---|
| Receipt number | R000027875 |
| Scientific Title | Endoscopic surgery for thyroid and parathyroid |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/10/08 19:18:46 |
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Basic information
Public title
Endoscopic surgery for thyroid and parathyroid
Acronym
Endoscopic surgery for thyroid and parathyroid
Scientific Title
Endoscopic surgery for thyroid and parathyroid
Scientific Title:Acronym
Endoscopic surgery for thyroid and parathyroid
Region
| Japan |
Condition
Condition
benign thyroid nodule, Graves disease, hyperparathyroidism
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify safety and efficacy of endoscopic surgery for thyroid and parathyroid.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
therapeutic efficacy of surgery
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
| Maneuver |
Interventions/Control_1
endoscopic surgery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients, who will have elective surgery for benign thyroid nodule or Graves disease or primary hyperparathyroidism.
Key exclusion criteria
Patients, who had neck surgery.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kosho |
| Middle name | |
| Last name | Yamanouchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7316
ymanouch@gk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kosho |
| Middle name | |
| Last name | Yamanouchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7316
Homepage URL
ymanouch@gk9.so-net.ne.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Clinical Research Center, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7726
ymanouch
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
| 2016 | Year | 10 | 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
0
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2016 | Year | 09 | Month | 28 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027875
