Non interventional post-authorisation safety study (PASS) to define the incidence of and potential risk factors for procedure-related neurological adverse events (AE) in patients undergoing ultrasound guided foam sclerotherapy (UGFS) for the treatment of lower limb varicose veins (VV) using Fibrovein 3% and 1% (sodium tetradecyl sulphate, STS, injection) incorporating a drug utilisation study (Fibrovein PASS)

15/01/2015
02/07/2024
EU PAS number:
EUPAS8260
Study
Finalised
Study identification

EU PAS number

EUPAS8260

Study ID

38779

Official title and acronym

Non interventional post-authorisation safety study (PASS) to define the incidence of and potential risk factors for procedure-related neurological adverse events (AE) in patients undergoing ultrasound guided foam sclerotherapy (UGFS) for the treatment of lower limb varicose veins (VV) using Fibrovein 3% and 1% (sodium tetradecyl sulphate, STS, injection) incorporating a drug utilisation study (Fibrovein PASS)

DARWIN EU® study

No

Study countries

France
United Kingdom

Study description

This is a non-interventional PASS to define the incidence and risk factors for procedure-related neurological AE in patients having Fibrovein ultrasound guided foam sclerotherapy (UGFS) for varicose veins (VV)incorporating a drug utilisation study. The research questions are: 1. What are the incidence, type, severity, duration, treatment (where required), and outcome of procedure-related neurological AE in patients undergoing UGFS for lower limb VV using Fibrovein? 2. To what extent, if any, are these procedure-related neurological AE associated with identifiable patient and treatment characteristics? 3. Post-marketing authorisation (PMA), how is UGFS with Fibrovein being used in the “real world” to treat lower limb VVs (nested drug utilisation study)? The population to be studied comprises adult, non-pregnant, non-breast-feeding, patients undergoing UGFS with Fibrovein for VV. Patient and treatment variables will be collected on Proforma 1. These will include age, gender, BMI, primary versus recurrent, deep venous disease and/or DVT, CEAP grade, type of VV, history of migraine / TIA / stroke / diabetes / high BP, smoking status, known PFO, previous Fibrovein UGFS, unilateral vs. bilateral treatment, method of foam preparation, Fibrovein volume concentration and gas ratio, gas used, number of injections, concomitant treatments, compression regime and duration. Co-investigators will contact the UK Co-ordinating Centre should a SAE occur at the time of treatment or subsequently (details recorded on Proforma 2). Data will be recorded for 10,000 treatments. Non-patient-identifiable data will be entered to a password-protected computerised database. Descriptive and summary statistics will be used. If the incidence of neurological AE is 0.35%, 10,000 will provide an 80% chance (power) of showing that rate is significantly below 0.5% at the 5% significance level. Patients will be treated according to contemporary “standards of care” at each participating centr

Study status

Finalised

Contact details

Bradbury Andrew

Primary lead investigator

Study timelines

Date when funding contract was signed

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Actual:

Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

STD Pharmaceuticals Ltd
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)