Randomised trial of gelatin versus embospheres for uterine fibroid embolisation
| ISRCTN | ISRCTN71074145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71074145 |
| Secondary identifying numbers | CZB/4/683 |
- Submission date
- 27/08/2008
- Registration date
- 23/09/2008
- Last edited
- 20/09/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Radiology
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom
| Jon.moss@ggc.scot.nhs.uk |
Study information
| Study design | Open randomised equivalence trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Uterine artery embolisation for symptomatic fibroids: Comparison of gelatin sponge with embospheres as an embolic agent - a randomised controlled trial (GEM trial) |
| Study acronym | GEM |
| Study objectives | Randomised controlled trial (RCT) comparing gelatin sponge with Embosphere® for uterine artery embolisation for women with uterine fibroids. |
| Ethics approval(s) | West Glasgow Ethics Committee approval pending as of 11/02/2009 |
| Health condition(s) or problem(s) studied | Uterine fibroids |
| Intervention | Uterine artery embolisation with either gelatin sponge or Embosphere®. Total duration of follow-up: 12 months |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Degree of fibroid infarction using contrast enhanced MRI, assessed at baseline, 1, 6 and 12 months |
| Secondary outcome measures | Assessed at baseline, 1, 6 and 12 months: 1. Ovarian function and reserve 2. Quality of life, assessed by Euroqol, Uterine Fibroid Symptom and Quality of Life questionnaire (UFSQoL) 3. Symptom relief, assessed by a linear 11-point score -5 through zero to + 5 4. Reintervention rate |
| Overall study start date | 01/01/2010 |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Patients referred for uterine artery embolisation Added 13/02/2009: 2. Females aged 18 - 55 years |
| Key exclusion criteria | 1. Pregnant 2. Allergy to radiographic contrast media 3. Unable to tolerate magnetic resonance imaging (MRI) scan |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
G12 OYN
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Melissa McBride
R&D
38 Church Street
Western Infirmary
Glasgow
G3 8YU
Scotland
United Kingdom
| Phone | +44 (0)1412 118548 |
|---|---|
| Melissa.mcbride@ggc.scot.nhs.uk | |
| Website | http://www.nhsgg.org.uk |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/09/2017: The trial was stopped.
11/02/2009: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/06/2009 to 01/01/2010.
2. The funder field was changed from 'Chief Scientist Office (UK) (ref: CZB/4/683)' (grant submission rejected) to 'The Wellcome Trust (UK) - applied for funding, not confirmed yet'
