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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jonathan Moss
Scientific

Department of Radiology
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom

Email	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

Gartnavel General Hospital

Glasgow
G12 OYN
United Kingdom

Sponsor information

Greater Glasgow and Clyde NHS Board (UK)
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
Email	Melissa.mcbride@ggc.scot.nhs.uk
Website	http://www.nhsgg.org.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

The Wellcome Trust (UK) - applied for funding, not confirmed yet

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'