Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

NCT ID: NCT02449304

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-04-30

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.

Conditions

Heavy Menstrual Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endometrial ablation (4th gen)

Intervention Type: DEVICE

Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining

Interventions

Endometrial ablation (4th gen)

Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Birmingham Women's NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Thomas Justin Clark

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Birmingham Women's NHS Foundation Trust

References

1. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. Evidence-Based Clinical Guideline No.4.London: RCOG Press; 1999.

Reference Type: BACKGROUND

2. Royal College of Obstetricians and Gynaecologists. The Management of Menorrhagia in Secondary Care. Evidence-Based Clinical Guideline No.5.London: RCOG Press; 1999.

Reference Type: BACKGROUND

Other Identifiers

BirminghamWHC

Identifier Type: -

Identifier Source: org_study_id