Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2021-12-31

Brief Summary

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This study will be comparing the treatment of varicose veins using either mechanochemical ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving either MOCA or CAE.

The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be assessed.

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Detailed Description

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This will be a randomised clinical trial comparing MOCA to CAE. Patients will be randomised into group A (MOCA) or group B (CAE). Only the endovenous ablation part of the procedure will be randomised while the decision as to whether patients should receive treatment of their varicose tributaries will be at the discretion of the clinical team.

The device used for MOCA (group A) will be the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).

The device used for CAE (group B) will be the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).

Re-intervention of the treated saphenous veins will not be decided until at least 3 months after their initial procedure.

Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

An internet-based randomisation service will be used Outcome assessors will be blinded as to treatment offered

Study Groups

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Mechanochemical ablation (MOCA)

Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).

Group Type ACTIVE_COMPARATOR

Mechanochemical ablation

Intervention Type PROCEDURE

Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)

Cyanoacrylate adhesive (CAE)

Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).

Group Type ACTIVE_COMPARATOR

Cyanoacrylate adhesive

Intervention Type PROCEDURE

Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)

Interventions

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