UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014301 |
|---|---|
| Receipt number | R000016655 |
| Scientific Title | micro-marsupialization for the treatment of mucous-retention cysts |
| Date of disclosure of the study information | 2014/06/20 |
| Last modified on | 2021/01/08 10:51:22 |
* 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
micro-marsupialization for the treatment of mucous-retention cysts
Acronym
micro-marsupialization for the treatment of mucous-retention cysts
Scientific Title
micro-marsupialization for the treatment of mucous-retention cysts
Scientific Title:Acronym
micro-marsupialization for the treatment of mucous-retention cysts
Region
| Japan |
Condition
Condition
mucous-retention cysts
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Attempts to micro-marsupialization with respect to mucous-retention cysts, consider outcomes, adaptation cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change before and after treatment of mucous-retention cysts.
Key secondary outcomes
Improvement of the tumor
Improvement of subjective symptoms
Adverse event
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
| Maneuver |
Interventions/Control_1
Suturing in the cyst wall on to penetrate the cyst cavity silk.
Get the effect by fenestration fenestration hole formed by radical healing of the cyst wall in contact with the silk thread.
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
1.Patients who have been diagnosed mucus cyst(mucus aneurysm, ranine).
2.Patients with the intent and ability of the hospital
3.After receiving a sufficient explanation Upon participation in this study, on a full understanding, patients who obtained the document voluntary consent of (guardian if a minor) patient himself.
Key exclusion criteria
1.Patients suffering from severe diabetes.
2. Patients suffering from infectiousdiseases having a difficult to control activity.
3. Patients have a liver dysfunction.
4. Patients suspected of pregnancy or are pregnant.
5. Patients principal investigator was deemed inappropriate as subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroe Kakehashi |
Organization
Nagasaki University Hospital
Division name
department of Regerative Oral Surgery
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7704
khiroe@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroe Kakehashi |
Organization
Nagasaki University Hospital
Division name
department of Regerative Oral Surgery
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7704
Homepage URL
khiroe@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2014 | Year | 06 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2016 | 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
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016655
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
