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Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

Primary Purpose

Heavy Menstrual Bleeding

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Endometrial ablation (4th gen)
Sponsored by
Birmingham Women's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding focused on measuring endometrial ablation, heavy menstrual bleeding, novosure

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Endometrial Ablation (4th gen)

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Visual analogue scale for assessment of pain
    This technique involves use of 10 cm line on a piece of paper representing a continuum of the patients' opinion of the degree of pain. It is explained to the patient that the one extreme of the line represents "no pain at all" while the other represents "as much pain as she can possibly imagine". The subject rates the degree of pain by placing a mark on the line and scale values are obtained by measuring the distance from zero to that mark. The reliability of visual analogue scales in the assessment of pain has been established as reproducible and accurate. These scales will be administered in our study immediately following treatment, at one hour post treatment and on discharge from hospital.
    Disease specific health-related quality of life
    The multi-attribute utility assessment for menorrhagia questionnaire attempts to capture the consequences of menorrhagia on these domains with 6 questions each with 4 levels of response giving an overall composite score out of 100.

    Full Information

    First Posted
    May 13, 2015
    Last Updated
    May 16, 2015
    Sponsor
    Birmingham Women's NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02449304
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    October 2015 (Anticipated)
    Study Completion Date
    April 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Birmingham Women's NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heavy Menstrual Bleeding
    Keywords
    endometrial ablation, heavy menstrual bleeding, novosure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Endometrial Ablation (4th gen)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Endometrial ablation (4th gen)
    Intervention Description
    Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining
    Primary Outcome Measure Information:
    Title
    Amenorrhoea
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Visual analogue scale for assessment of pain
    Description
    This technique involves use of 10 cm line on a piece of paper representing a continuum of the patients' opinion of the degree of pain. It is explained to the patient that the one extreme of the line represents "no pain at all" while the other represents "as much pain as she can possibly imagine". The subject rates the degree of pain by placing a mark on the line and scale values are obtained by measuring the distance from zero to that mark. The reliability of visual analogue scales in the assessment of pain has been established as reproducible and accurate. These scales will be administered in our study immediately following treatment, at one hour post treatment and on discharge from hospital.
    Time Frame
    6 months
    Title
    Disease specific health-related quality of life
    Description
    The multi-attribute utility assessment for menorrhagia questionnaire attempts to capture the consequences of menorrhagia on these domains with 6 questions each with 4 levels of response giving an overall composite score out of 100.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Justin Clark, MD
    Organizational Affiliation
    Birmingham Women's NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

    Learn more about this trial

    Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

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