UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036727 |
|---|---|
| Receipt number | 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 15:41:28 |
* 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
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
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/
j.nugroho.eko@fk.unair.ac.id
Sponsor or person
Institute
None declared
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041849
