Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

NCT02449304 | Unknown Phase 4

• 1 other identifier: BirminghamWHC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

endometrial ablation, heavy menstrual bleeding, novosure

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Visual analogue scale for assessment of pain

  6 months

• Disease specific health-related quality of life

  6 months

Study Arms (1)

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.

Device: Endometrial ablation (4th gen)

Interventions

Endometrial ablation (4th gen) DEVICE

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

Endometrial Ablation (4th gen)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead

Related Publications (2)

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

  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.

  BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Interventions

Endometrial Ablation Techniques

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Justin Clark, MD

  Birmingham Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 20, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2020
• Last Updated: May 20, 2015

Record last verified: 2015-05