Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

Birmingham Women's NHS Foundation Trust

Status and phase: Unknown; Phase 4

Conditions: Heavy Menstrual Bleeding

Treatments: Device: Endometrial ablation (4th gen)

Study type: Interventional

Funder types: Other

Identifiers

NCT02449304

BirminghamWHC

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Endometrial Ablation (4th gen)

Experimental group

Description:

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.

Treatment:

Device: Endometrial ablation (4th gen)