A randomised controlled double blind trial comparing thermal balloon endometrial ablation (Cavaterm) and microwave endometrial ablation
| ISRCTN | ISRCTN33718483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33718483 |
| Secondary identifying numbers | UHL9832 |
- Submission date
- 12/04/2005
- Registration date
- 13/07/2005
- Last edited
- 05/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Philip Kirwan
Scientific
Scientific
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
| Phone | +44 (0)116 258 4832 |
|---|---|
| philip.kirwan@uhl-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study hypothesis | Outcomes/compliance/pain following each treatment may be significantly different |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Menorrhagia |
| Intervention | Thermal Balloon Ablation versus Microwave Ablation |
| Intervention type | Other |
| Primary outcome measure | Reduction in menstrual loss and pain |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2005 |
| Overall study end date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 220 |
| Participant inclusion criteria | Women with heavy menstrual bleeding due to hormonal dysfunction |
| 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
- England
- United Kingdom
Study participating centre
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)116 258 4832 |
|---|---|
| philip.kirwan@uhl-tr.nhs.uk | |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
University Hospitals of Leicester NHS Trust - an "own account" trial, funded via the NHS R&D Support Funding stream
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2006 | Yes | No |
