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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014301
Receipt No. 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

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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
Email 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
Email khiroe@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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