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A Study to Compare the Effectiveness of Two Different Outpatient Endometrial Ablation Techniques Used for Heavy Periods

Launched by BIRMINGHAM WOMEN'S NHS FOUNDATION TRUST · May 14, 2010

Trial Information

Current as of April 25, 2025

Completed

Keywords

Heavy Menstrual Bleeding Menorrhagia Thermachoice Tm Nova Sure Tm Endometrail Ablation

ClinConnect Summary

Heavy menstrual bleeding (HMB) or 'menorrhagia' is a common condition with a major impact on health-related quality of life and health resource utilization in both primary and secondary care. In over 50% of cases no organic pathology is present and the term dysfunctional uterine bleeding (DUB) is used. First line treatment of DUB is medical and where this fails, surgery is indicated using either minimally invasive approaches (endometrial ablation) or major surgery (hysterectomy). Endometrial ablation has been extensively evaluated against the gold standard of hysterectomy and shown to be ef...

Gender

FEMALE

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
  • Premenopausal follicular follicle stimulating hormone (FSH) level of less than 40 IU/L.
  • 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)

About Birmingham Women's Nhs Foundation Trust

Birmingham Women's NHS Foundation Trust is a leading healthcare organization dedicated to providing high-quality women's and neonatal services. Committed to advancing clinical research, the Trust plays a pivotal role in conducting innovative clinical trials that aim to improve health outcomes for women and their families. With a multidisciplinary approach, the Trust collaborates with various stakeholders to ensure rigorous scientific standards and ethical practices are upheld in all research initiatives. Its focus on patient-centered care and commitment to excellence positions Birmingham Women's NHS Foundation Trust as a key contributor to advancements in women's health and medical research.

Locations

Patients applied

0 patients applied

Trial Officials

Justin Mr Clark, MD MRCOG

Principal Investigator

Birmingham Women's NHS Foundation Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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