UMIN-CTR Clinical Trial

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