NCT02449304

Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

Evaluation of Feasibility and Effectiveness of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device: a Cohort Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Birmingham Women's NHS Foundation Trust · Other Government
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Endometrial ablation (4th gen)	Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2020-04-01
• First posted: 2015-05-20
• Last updated: 2015-05-20