Condition category
Cancer
Date applied
27/08/2008
Date assigned
23/09/2008
Last edited
03/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Moss

ORCID ID

Contact details

Department of Radiology
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom
-
Jon.moss@ggc.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZB/4/683

Study information

Scientific title

Uterine artery embolisation for symptomatic fibroids: Comparison of gelatin sponge with embospheres as an embolic agent - a randomised controlled trial (GEM trial)

Acronym

GEM

Study hypothesis

Randomised controlled trial (RCT) comparing gelatin sponge with Embosphere® for uterine artery embolisation for women with uterine fibroids.

Ethics approval

West Glasgow Ethics Committee approval pending as of 11/02/2009

Study design

Open randomised equivalence trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Uterine fibroids

Intervention

Uterine artery embolisation with either gelatin sponge or Embosphere®.
Total duration of follow-up: 12 months

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Degree of fibroid infarction using contrast enhanced MRI, assessed at baseline, 1, 6 and 12 months.

Secondary outcome measures

The following will be assessed at baseline, 1, 6 and 12 months:
1. Ovarian function and reserve
2. Quality of life: 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 trial start date

01/01/2010

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients referred for uterine artery embolisation

Added 13/02/2009:
2. Females aged 18 - 55 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Pregnant
2. Allergy to radiographic contrast media
3. Unable to tolerate magnetic resonance imaging (MRI) scan

Recruitment start date

01/01/2010

Recruitment end date

01/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gartnavel General Hospital
Glasgow
G12 OYN
United Kingdom

Sponsor information

Organisation

Greater Glasgow and Clyde NHS Board (UK)

Sponsor details

c/o Melissa McBride
R&D
38 Church Street
Western Infirmary
Glasgow
G3 8YU
United Kingdom
+44 (0)1412 118548
Melissa.mcbride@ggc.scot.nhs.uk

Sponsor type

Government

Website

http://www.nhsgg.org.uk

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/03/2016: No publications found, verifying study status with principal investigator. On 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'