NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding

NCT05856838 | Recruiting

• 1 other identifier: ONZ-2023-0131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified. The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications. An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia. The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours) This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout). The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.

Conditions

Menstrual Bleeding, Heavy

Keywords

Menorrhagia/surgery; Endometrial Ablation Techniques; Endometrium/surgery

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction assessed bij a 5-point Likert Scale

  Patient satisfaction of the procedure on a 5-point Likert Scale

  3 months after the procedure

Secondary Outcomes (8)

• Pain assessed by VAS

  During the procedure and 2 hours after the procedure

• Symptom relief assessed bij a 5-point Likert Scale

  3 months after the procedure.

• Amenorrhea rate

  at 6 weeks and 3 months after the procedure.

• Menstrual blood loss

  1 month before and 3 months after the procedure.

• Health related quality of life assessment

  1 month before and 3 months after the procedure.

Study Arms (1)

NovaSure ablation

EXPERIMENTAL

Device: NovaSure ablation

Interventions

NovaSure ablation DEVICE

Ablation of the endometrial tissue using the NovaSure device

NovaSure ablation

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 35 years - ≤ 50 years
• Heavy menstrual bleeding (PBAC ≥ 150)
• Unsuccessful drug treatment, contraindication to drug treatment or rejection of drug treatment by the patient
• The absence of intra-uterine abnormalities on diagnostic hysteroscopy
• Endometrial biopsy (pipelle) is normal
• Finished childbearing

You may not qualify if:

• Pregnancy
• Endometritis
• Adenomyosis
• Contra-indication for local anaesthetics
• Presence of severe systemic disease (≥ASA 3)
• Previously performed endometrial ablation
• Poor understanding of Dutch language
• History of pelvic malignancy
• Presence of an intra uterine device (IUD)
• Cavity pathology (myoma, septum)
• Cavity length \< 4 cm
• Each uterine incision other than conventional caesarean incision

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Menorrhagia

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

Central Study Contacts

Studies Vrouwenkliniek

CONTACT

+32 9 332 37 83; studieco.vrouwenkliniek@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: November 24, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)