UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056688 |
|---|---|
| Receipt number | R000064798 |
| Scientific Title | Prospective Interventional Study in the Incidence of Adverse Events after Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/11 11:43:44 |
* 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
Prospective Interventional Study in the Incidence of Adverse Events after Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin
Acronym
Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin
Scientific Title
Prospective Interventional Study in the Incidence of Adverse Events after Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin
Scientific Title:Acronym
Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin
Region
| Japan |
Condition
Condition
Vocal nodules Vocal polyps
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to evaluate the feasibility of performing laryngeal microsurgery without discontinuing low-dose oral contraceptives, thereby preventing the exacerbation of dysmenorrhea symptoms while ensuring safe and prompt treatment. This approach aims to enhance patient satisfaction and improve the quality of medical care.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Performing microsurgical laryngeal procedures that are completed in a short period of time without discontinuation of low-dose pills in the 4 weeks prior to the perioperative period.
This is an interventional study involving medical treatment beyond the scope of normal medical practice because the use of the approved drug or medical device is beyond the scope of approval, etc. (usage).
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Patients who visit Tokyo Voice Center on or after the date of approval and are scheduled to undergo microlaryngeal surgery under general anesthesia with a diagnosis of vocal nodule or vocal polyp
(1) Patients taking low-dose pills who are scheduled to undergo microlaryngeal surgery under general anesthesia at Tokyo Voice Center on or after the date of approval
(2) Patients who are able to obtain written consent to participate in the research of their own free will.
(3) Patients who are between 18 and 50 years of age at the time of consent
(4) Gender: Female
Key exclusion criteria
(1) Those with laryngeal diseases other than vocal nodules or vocal polyps
(2) Patients with serious renal, cardiovascular, hematological (hereditary blood coagulation abnormalities), hepatic, and respiratory diseases
(3) Patients with cancer and those undergoing anticancer drug treatment
(4) Women who are pregnant or may become pregnant
(5) Patients with cognitive impairment
(6) Patients with a history of hypersensitivity to this drug (trafermin)
(7) Patients who have participated in other clinical trials or clinical studies within 12 weeks prior to obtaining consent
(8) Patients with a history of alcohol dependence or drug abuse
(9) Undergraduate and graduate students of the University
(10) Other patients deemed inappropriate for this study by the principal investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Watanabe |
Organization
International University of Health and Welfare
Division name
Tokyo Voice Center
Zip code
107-0052
Address
8-5-35 Akasaka, Minato-ku, Tokyo
TEL
03-3402-5581
nabe@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Hasegawa |
Organization
International University of Health and Welfare
Division name
Tokyo Voice Center
Zip code
107-0052
Address
8-5-35 Akasaka, Minato-ku, Tokyo
TEL
03-3402-5581
Homepage URL
t-hasegawa1@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
none
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
Junwakai Research Ethics Committee
Address
8-10-16 Akasaka, Minato-ku, Tokyo
Tel
03-3402-3151
t-mimura@iuhw.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
| 2025 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 01 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064798
