UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011833
Receipt number R000013833
Scientific Title Clinical evaluation of new vitrectomy system:EVA
Date of disclosure of the study information 2014/02/01
Last modified on 2016/09/24 10:51:49

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Basic information

Public title

Clinical evaluation of new vitrectomy system:EVA

Acronym

Clinical evaluation of EVA

Scientific Title

Clinical evaluation of new vitrectomy system:EVA

Scientific Title:Acronym

Clinical evaluation of EVA

Region

Japan


Condition

Condition

Retinal detachment, Epimacular proliferation, macular hole, Diabetic retinopathy, Retinal vein occlusion, Vitreous hemorrhage

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Vitrectomy is indicated for various vitreoretial disorders, including retinal dtachment, epimacular proliferation, diabetic retinopathy, retinal vein occlusion, and vitreous hemorrhage. In order to perform vitrectomy, vitrectomy surgery system is necessary. Dutch Ophthalmic Research Center (DORC) has introduced a new vitrectomy system, EVA, which has already obtained CE approval and on the European market nearly one year (as of September, 2013). Registration of EVA for Pharmaceutical and Medical Devices Agency of Japan is being processed.
Compared with the current vitrectomy system, EVA is equipped with various innovative features, including high-speed cutter up to 8,000rpm, a new vacuum system (VacuFlow VTi technology), and LED light sources. These new features are supposed to increase EVA's safety, efficiency, and reliability.
The purpose of this study is to test EVA's safety, efficiency, and reliability in real clinical situations before its introduction to Japanese Market.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Surgical time for each procedure, complications, and volume of intraocular irrigation at the time of surgery

Key secondary outcomes

Usability of vitrectomy system


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Perform primary vitrectomy using a new vitrectomy system EVA, excluidng reoperation.

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

Patients who are in need of vitrectomy for retinal detachment, epimacular proliferation, macular hole, diabetic retinopathy, or vitreous hemorrhage.

Key exclusion criteria

Patients who does not consent to this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunji Kusaka

Organization

Sakai Hospital Kinki University Faculty of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-7-1 Minami-ku, Sakai, 590-0132, Osaka, JAPAN

TEL

072-299-1120

Email

kusaka-ns@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Shunji Kusaka

Organization

Sakai Hospital Kinki University Faculty of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-7-1 Minami-ku, Sakai, 590-0132, Osaka, JAPAN

TEL

072-299-1120

Homepage URL


Email

kusaka-ns@umin.net


Sponsor or person

Institute

Kinki University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Dutch Ophthalmic Research Center (DORC)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Holland


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

近畿大学医学部堺病院(大阪府)


Other administrative information

Date of disclosure of the study information

2014 Year 02 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

Preclinical trial of EVA for vitrectomy was conducted. There were no problems during vitrectomy. EVA seems to be excellent system for vitrectomy.

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

2013 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 01 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry

2014 Year 05 Month 31 Day

Date trial data considered complete

2014 Year 05 Month 31 Day

Date analysis concluded

2014 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 09 Month 22 Day

Last modified on

2016 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name