Trials / Completed
CompletedNCT03392753
Mechanochemical Ablation Compared to Cyanoacrylate Adhesive
Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 167 (actual)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Mechanochemical ablation | Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein) |
| PROCEDURE | Cyanoacrylate adhesive | Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM) |
Timeline
- Start date
- 2017-11-06
- Primary completion
- 2019-07-31
- Completion
- 2021-12-31
- First posted
- 2018-01-08
- Last updated
- 2022-08-04
- Results posted
- 2021-12-07
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03392753. Inclusion in this directory is not an endorsement.