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
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
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
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
