Condition category
Urological and Genital Diseases
Date applied
12/04/2005
Date assigned
13/07/2005
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively 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

Dr Philip Kirwan

ORCID ID

Contact details

Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4832
philip.kirwan@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UHL9832

Study information

Scientific title

Acronym

Study hypothesis

Outcomes/compliance/pain following each treatment may be significantly different

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Menorrhagia

Intervention

Thermal Balloon Ablation versus
Microwave Ablation

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reduction in menstrual loss and pain

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2005

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Women with heavy menstrual bleeding due to hormonal dysfunction

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

220

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2005

Recruitment end date

31/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester General Hospital
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4832
philip.kirwan@uhl-tr.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

University Hospitals of Leicester NHS Trust - an "own account" trial, funded via the NHS R&D Support Funding stream

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17130037

Publication citations

  1. Results

    Sadoon SS, Salman GA, Kirwan P, Thermal balloon endometrial ablation (Cavaterm) in the management of menorrhagia., J Obstet Gynaecol, 2006, 26, 8, 804-805, doi: 10.1080/01443610600984495.

Additional files

Editorial Notes