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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036727
Receipt No. R000041849
Scientific Title Mechanical occlusion chemically assisted ablation (MOCA) for saphenous vein insufficiency: A metaanalysis of randomized-trial
Date of disclosure of the study information 2019/05/13
Last modified on 2019/05/13

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Basic information
Public title Mechanical occlusion chemically assisted ablation (MOCA) for varicose vein: A metaanalysis of randomized-trial
Acronym Mechanical occlusion chemically assisted ablation (MOCA) for varicose vein: A metaanalysis of randomized-trial
Scientific Title Mechanical occlusion chemically assisted ablation (MOCA) for saphenous vein insufficiency: A metaanalysis of randomized-trial
Scientific Title:Acronym MOCA for saphenous vein insufficiency: A metaanalysis of randomized-trial (MOCA) for saphenous vein insufficiency: A metaanalysis
Region
Asia(except Japan)

Condition
Condition Saphenous vein insusfficiency
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Since medium-term to long-term data on randomized-clinical trial are becoming available, we want to perform meta-analysis of randomized-trials to assess the efficacy and safety of MOCA for saphenous vein insufficiency.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome in our meta-analysis was anatomical failure, defined as presence of complete or parsial recanalization more than 10 cm or more than 5 cm at distal part on duplex ultrasound (DUS) imaging. The primary outcome was categorized in short term (1 month) and long term (greater than 6 months) follow-up periods.
Key secondary outcomes Secondary outcomes were change from baseline of AVVQ score at follow up period and major adverse events including DVT, sensoric disturbance, skin burns.

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria All RCTs comparing anatomical success of MOCA for saphenous vein insufficiency (either great saphenous vein (GSV), small saphenous vein (SSV) or both) to endovenous thermal ablation
Key exclusion criteria All trials comparing MOCA to other than endovenous thermal ablation
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Johanes
Middle name
Last name Nugroho
Organization Faculty of Medicine Universitas Airlangga,
Dr. Soetomo General Hospital, Surabaya, East Java Indonesia
Division name Department of Cardiology and Vascular Medicine
Zip code 60131
Address Jl. Mayjen Prof. Dr. Moestopo 47, Surabaya
TEL +6282139090953
Email j.nugroho.eko@fk.unair.ac.id

Public contact
Name of contact person
1st name Johanes
Middle name
Last name Nugroho
Organization Faculty of Medicine Universitas Airlangga, Dr. Soetomo General Hospital, Surabaya, East Java Indone
Division name Department of Cardiology and Vascular Medicine
Zip code 60131
Address Jl. Mayjen Prof. Dr. Moestopo 47, Surabaya
TEL +6282139090953
Homepage URL http://fk.unair.ac.id/en/
Email j.nugroho.eko@fk.unair.ac.id

Sponsor
Institute None declared
Institute
Department

Funding Source
Organization None declared
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Komite Etik Penelitian Kesehatan (KEPK) FK Unair
Address Kampus A UNAIR Jl. Mayjen Prof. Dr. Moestopo 47, Surabaya 60131
Tel +62315020251
Email info@fk.unair.ac.id

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 05 Month 13 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 100
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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 08 Day
Date of IRB
2019 Year 05 Month 10 Day
Anticipated trial start date
2019 Year 05 Month 14 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a meta-analysis of all RCTs comparing anatomical success of MOCA for saphenous vein insufficiency (either great saphenous vein (GSV), small saphenous vein (SSV) or both) to endovenous thermal ablation.

Management information
Registered date
2019 Year 05 Month 13 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041849

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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