Heavy Menstrual BleedingPhase 4NCT02449304
Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device
A Phase 4 study testing Endometrial ablation (4th gen) in people with Heavy Menstrual Bleeding, run by Birmingham Women's NHS Foundation Trust.
Trial summary
All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Endometrial ablation (4th gen)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
- Associated functional disability (negative impact on life quality).
- Lack of response to medical treatment.
- Prepared to undergo surgical treatment without general anaesthesia
Who cannot join
- Women under 25 years
- Suspected genital tract infection
- Uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids > 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
- Uterine cavity length >11cm
- Adnexal pathology
- Previous open myomectomy or endometrial ablation / resection and classical caesarian section
- Patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)
About this study
Official title: Evaluation of Feasibility and Effectiveness of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device: a Cohort Study
All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial ablation in either an inpatient or outpatient setting according to their preference.
Outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. After the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Endometrial ablation (4th gen)
- Keywords
- endometrial ablation, heavy menstrual bleeding, novosure
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial ablation (4th gen)Device
Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining
| Study group | Role | What they receive |
|---|---|---|
| Endometrial Ablation (4th gen) | Experimental | A single-centre uncontrolled observational study is proposed. All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents, who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo RFA G4 endometrial ablation in either an inpatient or outpatient setting according to their preference. Receives: Device: Endometrial ablation (4th gen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amenorrhoea
Two Likert-type ordinal scales will be used to assess the change in menstrual blood loss using the questions and following response categories: 'How would you describe your menstrual periods?': 'No bleeding', 'Spotting or discharge only', 'Light bleeding', 'Moderate bleeding', 'Heavy bleeding' and 'Compared to before treatment, would you say that your heavy menstrual bleeding is: 'Much better, 'A little better', 'Same', 'Worse'. These scales will be administered in our study at 6, 12 and 60 months after the intervention.
Measured: 6 months
Secondary outcomes (2)
Visual analogue scale for assessment of pain
This technique involves use of 10 cm line on a piece of paper representing a continuum of the patients' opinion of the degree of pain. It is explained to the patient that the one extreme of the line represents "no pain at all" while the other represents "as much pain as she can possibly imagine". The subject rates the degree of pain by placing a mark on the line and scale values are obtained by measuring the distance from zero to that mark. The reliability of visual analogue scales in the assessment of pain has been established as reproducible and accurate. These scales will be administered in our study immediately following treatment, at one hour post treatment and on discharge from hospital.
Measured: 6 months
Disease specific health-related quality of life
The multi-attribute utility assessment for menorrhagia questionnaire attempts to capture the consequences of menorrhagia on these domains with 6 questions each with 4 levels of response giving an overall composite score out of 100.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thomas Justin Clark, Birmingham Women's NHS Foundation Trust
- Investigators
- Justin Clark, MD, Principal investigator, Birmingham Women's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449304
- Sponsor's protocol ID
- BirminghamWHC
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. Evidence-Based Clinical Guideline No.4.London: RCOG Press; 1999.
2. Royal College of Obstetricians and Gynaecologists. The Management of Menorrhagia in Secondary Care. Evidence-Based Clinical Guideline No.5.London: RCOG Press; 1999.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility and Effectiveness of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device: a Cohort Study
- ClinicalTrials.gov ID
- NCT02449304
- Acronym / sponsor ID
- BirminghamWHC
- Conditions
- Heavy Menstrual Bleeding
- Keywords
- endometrial ablation, heavy menstrual bleeding, novosure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial ablation in either an inpatient or outpatient setting according to their preference.
Outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. After the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial Ablation (4th gen) | Experimental | Device: Endometrial ablation (4th gen)A single-centre uncontrolled observational study is proposed. All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents, who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo RFA G4 endometrial ablation in either an inpatient or outpatient setting according to their preference. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
- Associated functional disability (negative impact on life quality).
- Lack of response to medical treatment.
- Prepared to undergo surgical treatment without general anaesthesia
Key exclusion criteria (7 listed)
- Women under 25 years
- Suspected genital tract infection
- Uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids > 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
- Uterine cavity length >11cm
- Adnexal pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial ablation (4th gen)Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining | Device | Endometrial Ablation (4th gen) |
Primary outcome
Amenorrhoea
Time frame: 6 months
Two Likert-type ordinal scales will be used to assess the change in menstrual blood loss using the questions and following response categories: 'How would you describe your menstrual periods?': 'No bleeding', 'Spotting or discharge only', 'Light bleeding', 'Moderate bleeding', 'Heavy bleeding' and 'Compared to before treatment, would you say that your heavy menstrual bleeding is: 'Much better, 'A little better', 'Same', 'Worse'. These scales will be administered in our study at 6, 12 and 60 months after the intervention.
2 secondary outcomes
Visual analogue scale for assessment of pain
Time frame: 6 months
Disease specific health-related quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Background1. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. Evidence-Based Clinical Guideline No.4.London: RCOG Press; 1999.
- Background2. Royal College of Obstetricians and Gynaecologists. The Management of Menorrhagia in Secondary Care. Evidence-Based Clinical Guideline No.5.London: RCOG Press; 1999.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Clark, MD principal investigator
Birmingham Women's NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endometrial ablation (4th gen) in people with Heavy Menstrual Bleeding, run by Birmingham Women's NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amenorrhoea (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02449304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.