UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026056
Receipt number R000029939
Scientific Title Evaluation of velopharyngeal closure by 4Dimaging using 320-detector-row computed tomography.
Date of disclosure of the study information 2017/02/10
Last modified on 2017/02/08 16:57:23

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Basic information

Public title

Evaluation of velopharyngeal closure by 4Dimaging using 320-detector-row computed tomography.

Acronym

Evaluation of velopharyngeal closure by 4D-CT.

Scientific Title

Evaluation of velopharyngeal closure by 4Dimaging using 320-detector-row computed tomography.

Scientific Title:Acronym

Evaluation of velopharyngeal closure by 4D-CT.

Region

Japan


Condition

Condition

Cleft lip and palate

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

By using 4D-CT, the evaluation velopharyngeal closure is performed.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The volume change of velopharyngeal closure

Key secondary outcomes

The evaluation score by speech therapist


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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Before the operation, 4D-CT is performed during speech in 10 seconds.

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

The patients with cleft lip and palate who are necessary to evaluate the velopharyngeal closure

Key exclusion criteria

The patients who are providing orthodontic treatment, who can not obtain rest during CT examination

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Kishi

Organization

Keio University Shool of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

0353633814

Email

kkishi@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiaki Sakamoto

Organization

Keio University School of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

0353633814

Homepage URL


Email

ysakamoto@z8.keio.jp


Sponsor or person

Institute

Keio University

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


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

慶應義塾大学病院(東京)


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 10 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 02 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 10 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 08 Day

Last modified on

2017 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029939


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name