UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031174 |
|---|---|
| Receipt number | R000035596 |
| Scientific Title | Utility of methylene blue in surgery for primary hyperparathyroidism |
| Date of disclosure of the study information | 2018/02/06 |
| Last modified on | 2018/02/06 19:20:32 |
* 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
Utility of methylene blue in surgery for primary hyperparathyroidism
Acronym
Methylene blue in surgery for hyperparathyroidism
Scientific Title
Utility of methylene blue in surgery for primary hyperparathyroidism
Scientific Title:Acronym
Methylene blue in surgery for hyperparathyroidism
Region
| Japan |
Condition
Condition
Hyperparathyroidism
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the efficiency of methylene blue in surgery for hyperparathyroidism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification rate for hyperparathyroid glands.
Key secondary outcomes
safty, time for surgery, blood loss, hospital stay, complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
methylene blue
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases with hyperparathyroidism who underwent surgery
Key exclusion criteria
Patients who do not give their informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Fujii |
Organization
Graduate School of Medicine, Gunma University
Division name
Division of breast and endocrine surgery
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL
027-220-7111
ftakaaki@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Fujii |
Organization
Same as above
Division name
Same as above
Zip code
Address
Same as above
TEL
027-220-7111
Homepage URL
ftakaaki@gunma-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Gunma University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Gunma 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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 06 | 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
| 2000 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2000 | 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
| 2018 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035596
