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 |
| Protocol serial number | UHL9832 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | University Hospitals of Leicester NHS Trust - an "own account" trial, funded via the NHS R&D Support Funding stream |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Outcomes/compliance/pain following each treatment may be significantly different |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Menorrhagia |
| Intervention | Thermal Balloon Ablation versus Microwave Ablation |
| Intervention type | Other |
| Primary outcome measure(s) |
Reduction in menstrual loss and pain |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 220 |
| Key inclusion criteria | Women with heavy menstrual bleeding due to hormonal dysfunction |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
