Study Stopped
Difficulty finding eligible patients
Endoveneous Histologic Study
Histopathological Study of the Vena Saphena Magna After Mechanochemical Endoveneous Ablation
1 other identifier
interventional
N/A
1 country
1
Brief Summary
A new technique, mechanochemical endovenous ablation (MOCA), using the ClariVein ® system is recently developed. To date, histopathological data after mechanochemical endovenous ablation are not known. The aim of this study is the histopathological analysis of venous injury using mechanochemical endovenous ablation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 28, 2018
November 1, 2018
2.9 years
October 13, 2017
November 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occlusion of the with Clarivein treated vein
Occlusion of the with the Clarivein (Aethoxysklerol) treated vein, check wheter or not treatment was succesfull.
2 years of inclusion and analyzation
Depth of damage inside and/or outside the venous wall
Depth of damage inside and/or outside the venous wall is to check whether or not the venous wall is damaged due to the Clarivein treatment
2 years of inclusion and analyzation
Secondary Outcomes (3)
Analysis of intraluminal clot / scar
2 years of inclusion and analyzation
Morphological changes of the saphenous nerve due to damage of treatment
2 years of inclusion and analyzation
Perivascular damage resulting from treatment
2 years of inclusion and analyzation
Study Arms (1)
Aethoxysklerol clarivein during leg amp
OTHERClarivein treatment with Aethoxysklerol in 5 patients during lower or upper leg amputation
Interventions
The Clarivein technique uses mechanical damage to the endothelium of the vein wall through a rotating tip of the catheter. At the same time a sclerosans is injected, causing occlusion of the vein. No heating is used in this technique .
Eligibility Criteria
You may qualify if:
- Elective indication for leg amputation
- Peripheral arterial disease
- Age \> 18 years
- Written informed consent
You may not qualify if:
- Patient is incapable of informed consent
- Pregancy and lactation
- Previous surgical or endovenous treatment of the greater saphenous vein in the amputed leg
- Great saphenous vein is used for bypass surgery
- INR \> 1.8
- ASA 5
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate
Arnhem, Gelderland, 68ooTA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MMPJ Reijnen, MD
Rijnstate
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Michel Reijnen, MD, PI, vascular surgeon
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 31, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
November 28, 2018
Record last verified: 2018-11