|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Randomised controlled trial of Particles used in Uterine fibRoid Embolisation (PURE) |
| ISRCTN | ISRCTN18191539 |
| DOI | 10.1186/ISRCTN18191539 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Randomised controlled trial of Particles used in Uterine fibRoid Embolisation (PURE) |
| Scientific title | Randomised controlled trial of Particles used in Uterine fibRoid Embolisation (PURE): Non-spherical polyvinyl alcohol versus calibrated hydrogel microspheres with polyzene coating |
| Acronym | PURE |
| Serial number at source | NRES study 12/LO/1581. Sponsor reference number: 12.0126. Study Protocol V1.1 |
| Study hypothesis | PURE study is designed to detect differences in outcome (clinical and radiological) between uterine artery embolisation performed with non-spherical polyvinyl alcohol (Contour PVA) versus calibrated hydrogel microspheres with polyzene coating (Embozenes) |
| Lay summary |
Background and study aims
Uterine fibroids are a common gynaecological condition affecting women of reproductive age. Approximately half of women with fibroids experience symptoms including heavy menstrual bleeding, abdominal pain and pressure, all of which can impact on quality of life. The choice of treatment is between surgical removal of the fibroids / womb (myomectomy or hysterectomy) or a minimally invasive treatment called uterine artery embolisation (UAE). UAE is a minimally invasive interventional radiology procedure which blocks the blood vessels supplying the uterus. These vessels are accessed via arteries in the groin and using a small tube (angiographic catheter) to inject biodegradable particles into the arteries supplying the uterus. The fibroids fail to regain a blood supply and undergo necrosis (cell death). Many different particulate agents are in use for UAE. The two agents in this study are Contour non-spherical polyvinyl alcohol (PVA) and Embozenes (Polyzene coated hydrogel microspheres). Both the embolic agents are safe and approved for use in uterine artery embolisation. Non-spherical polyvinyl alcohol (PVA) has been used for more than two decades and is inexpensive. However this embolic agent has a tendency to clump and can block larger calibre vessels than the specified diameter of the particle. New calibrated particles have been developed which do not clump with claims that this is advantageous. The calibrated particles have a cost implication and yet there is no current evidence to back the manufacturers’ and physicians’ claims that they are superior to non-spherical PVA. Both the agents are tiny inert plastic beads that are designed to block blood flow within arteries. Both embolic agents contain particles that are of a similar size range (350 to 1100 micrometres). As well as being minimally invasive, one of the advantages of UAE is its reduced cost compared with surgery. The results of the two particulate agents will be assessed comparing the improvement in the quality of life using validated QOL forms and fibroid infarction rates using routine contrast enhanced MRI scans at 6 months. Who can participate? Female patients aged 18-55 years with symptomatic fibroids admitted for uterine artery embolisation What does the study involve? Comparison of two embolic agents: 1. Contour Non-spherical polyvinyl alcohol (PVA). Boston Scientific, USA. CE 0197 2. Embozene Microspheres (calibrated hydrogel microspheres with polyzene coating). CeloNova Biosciences, USA. CE 0086 Aside from the difference in embolic particles used to block the arteries to the womb the rest of the clinical treatment is identical. Participants will be randomised to one embolic agent or the other. The study processes: interventional procedure; clinical care; follow-up; and post procedure MRI scans, are already standard practice in our institution and identical between the two study groups. What are the possible benefits and risks of participating? There are no specific benefits to study participants. The treatment given to patients in either treatment arm of the study is equally effective in current medical practice. Patients will have the same care during the procedure and close follow-up whether entered into the study or not. The substances injected are embolic agents consisting of inert plastic / polymer-based microspheres. Both embolic agents are CE marked and classed for commercial use for embolisation in uterine artery embolisation. There are procedural risks that are related to the angiographic study and vascular interventional techniques required to access the uterine arteries but are not specific to the embolic agents in this study. The risk benefit ratio of performing UAE has been well established and UAE has an excellent safety profile. Where is the study run from? This is a single centre study based at St George’s Healthcare NHS Trust in London. When is the study starting and how long is it expected to run for? The start date is January 2013 and the study will last approximately 2 years until the final participant completes 6 months follow-up. Who is funding the study? St George’s Healthcare NHS Trust, London, UK Who is the main contact? Dr Raj Das (Study coordinator / Principal Investigator) drrajdas@gmail.com |
| Ethics approval | NRES Dulwich, London, 11/01/2013, study reference: 12/LO/1581 |
| Study design | Prospective single blinded randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Uterine fibroids (leiomyoma) |
| Participants - inclusion criteria |
1. Symptomatic fibroids admitted for uterine artery embolisation
2. Female participants aged 18-55 years |
| Participants - exclusion criteria |
1. Recent or ongoing pelvic inflammatory disease
2. Severe radiographic contrast medium allergy. 3. Significant adenomyosis, as identified by transvaginal ultrasound or MRI. Concurrent adenomyosis where fibroids are believed to the predominant cause of symptoms will be eligible. 4. Positive pregnancy test 5. Refusal to accept hysterectomy, in the event of an intra-operative complication. 6. Suspected malignancy 7. Age< 18 8. Unable to provide informed consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity (Scotland) Act 2000. 9. A non English speaker where translation or interpretation facilities are insufficient to guarantee informed consent |
| Anticipated start date | 01/01/2013 |
| Anticipated end date | 01/01/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
Uterine artery embolisation performed using either:
1. Contour Non-spherical polyvinyl alcohol (PVA), Boston Scientific, USA. CE 0197 OR 2. Embozene Microspheres (calibrated hydrogel microspheres with polyzene coating), CeloNova Biosciences, USA. CE 0086 |
| Primary outcome measure(s) | To confirm whether microsphere embolic particles (Embozenes) improve patient’s quality of life compared with the standard agent of non-spherical PVA (Contour PVA). This is measured using the validated Uterine Fibroid Symptom and Health-related Quality of Life questionnaire (UFS-QOL). |
| Secondary outcome measure(s) |
1. Contrast-enhanced MRI performed before and 6 months after UAE
2. Percentage Fibroid infarction - total fibroid burden and dominant fibroid infarction 3. Uterine and dominant fibroid volume reductions |
| Sources of funding | St George’s Healthcare NHS Foundation Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Anna-Maria Belli |
| Address |
Department of Radiology
St George's Healthcare NHS Trust Blackshaw Road |
| City/town | London |
| Zip/Postcode | SW17 0QT |
| Country | United Kingdom |
| Sponsor | St George's Healthcare NHS Trust (UK) |
| Address |
c/o Ms Nadia Azzouzi
St George’s Joint Research Office Ground Floor, Hunter Wing St George’s University of London Cranmer Terrace, Tooting |
| City/town | London |
| Zip/Postcode | SW17 0RE |
| Country | United Kingdom |
| Sponsor website: | http://www.stgeorges.nhs.uk/ |
| Date applied | 02/02/2013 |
| Last edited | 21/02/2013 |
| Date ISRCTN assigned | 21/02/2013 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
