UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011833
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Kinki University Faculty of Medicine
Institute
Department

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
URL(English) https://upload.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


Contact us.