UMIN-CTR Clinical Trial

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
Last 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
1st 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