Clinical trial NCT02449304: Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device
Official title: Evaluation of Feasibility and Effectiveness of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device: a Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heavy Menstrual Bleeding
Keywords: endometrial ablation, heavy menstrual bleeding, novosure
Lead sponsor: Birmingham Women's NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2015-05-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
2. Associated functional disability (negative impact on life quality).
3. Lack of response to medical treatment.
4. Prepared to undergo surgical treatment without general anaesthesia

Exclusion Criteria:

1. Women under 25 years
2. Suspected genital tract infection
3. 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.
4. Uterine cavity length \>11cm
5. Adnexal pathology
6. Previous open myomectomy or endometrial ablation / resection and classical caesarian section
7. Patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)

Primary outcomes:
measure: Amenorrhoea
timeFrame: 6 months
Secondary outcomes:
measure: Visual analogue scale for assessment of pain
timeFrame: 6 months
measure: Disease specific health-related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Birmingham Women's NHS Foundation Trust
name: Justin Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. Evidence-Based Clinical Guideline No.4.London: RCOG Press; 1999.
citation: 2. Royal College of Obstetricians and Gynaecologists. The Management of Menorrhagia in Secondary Care. Evidence-Based Clinical Guideline No.5.London: RCOG Press; 1999.