UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036813
Receipt number R000041353
Scientific Title Multicenter, single-group, postoperative, clinical evaluation of patient treated with Sugita-clip.
Date of disclosure of the study information 2019/07/01
Last modified on 2020/11/20 09:47:05

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Basic information

Public title

Multicenter, single-group, postoperative, clinical evaluation of patient treated with Sugita-clip.

Acronym

Multicenter, single-group, postoperative, clinical evaluation of patient treated with Sugita-clip.

Scientific Title

Multicenter, single-group, postoperative, clinical evaluation of patient treated with Sugita-clip.

Scientific Title:Acronym

Multicenter, single-group, postoperative, clinical evaluation of patient treated with Sugita-clip.

Region

Japan


Condition

Condition

cerebral aneurysm

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the progress of patients treated with the device and the adverse events and failures caused by the device.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the progress of patients treated with the device by using the postoperative Modified Rankin Scale(mRS).

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who underwent clipping surgery for ruptured or unruptured cerebral aneurysms using the device from 1 January 2016 to 31 December 2017 (during the past 2 years).
(2) Patients who are evaluated by using mRS
(3) Patients who are at least 20 years old at the time of surgery (cerebral aneurysm clipping).

Key exclusion criteria

Patients who have indicated their intention (opt-out) to refuse to participate in this study

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Yoshio
Middle name
Last name Araki

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Neurosurgery

Zip code

466-8560

Address

65 Tsurumai-cho Showa-ku Nagoya-shi

TEL

052-744-2353

Email

kenji84u@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Uda

Organization

Nagoya University School of Medicine Hospital

Division name

Department of Neurosurgery

Zip code

466-8560

Address

65 Tsurumai-cho Showa-ku Nagoya-shi

TEL

052-744-2353

Homepage URL


Email

kenji84u@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Neurosurgery Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Mizuho Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University Graduate School of Medicine

Address

65 Tsurumai-cho Showa-ku Nagoya-shi

Tel

052-744-2973

Email

ethics@med.nagoya-u.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

2019 Year 07 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

Enrolling by invitation

Date of protocol fixation

2019 Year 01 Month 11 Day

Date of IRB

2019 Year 03 Month 04 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We investigate about the following information from medical record, and evaluate patient progress and effectiveness of clipping surgery by performing statistical analysis (1, background of study subjects, 2, mRS, 3, Hunt & Kosnik classification, 4, WFNS classification, 5, information about their operation, 6, imaging test, 7, adverse event, and 8, defect).


Management information

Registered date

2019 Year 05 Month 21 Day

Last modified on

2020 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name