NCT06122363

Brief Summary

The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

November 5, 2023

Last Update Submit

June 10, 2025

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

  • Pictorial Blood Assessment Chart (PBAC) score

    Blood loss of 1 month, measured by the number of needed tampons/pads and how heavily they are filled with blood. The higher the score, the more severe blood loss. From 150 points the amount is defined as heavy menstrual bleeding.

    24 months

Secondary Outcomes (4)

  • Rate of reintervention

    24 months

  • Dysmennorrhea

    24 months

  • Number of patients having controlled bleeding

    24 months

  • Satisfaction of the patient with the treatment

    24 months

Other Outcomes (1)

  • Number of possible prognostic variables predicting the occurrence of incomplete endometrial ablation.

    baseline

Study Arms (2)

Complete Novasure endometrial ablation

After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation

Device: hysteroscopy

Incomplete Novasure endometrial ablation

After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation

Device: hysteroscopy

Interventions

hysteroscopyDEVICE

uterine hysteroscopy right after Novasure endometrial ablation

Complete Novasure endometrial ablationIncomplete Novasure endometrial ablation

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmen can not suffer from heavy menstrual bleeding
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective cohort study was carried out using the data of women who participated in the MIRA study and the MIRA2 study including RCT and prospective cohort database. These women have given informed consent for their data to be used for future research into treatments for heavy menstrual bleeding. To be eligible for study inclusion, women had to suffer from heavy menstrual bleeding, and have undergone Novasure endometrial ablation at Máxima MC between January 2012 and July 2023. Women were excluded from the database if the hysteroscopy images were not saved, or these images were of poor quality.

You may qualify if:

  • Endometrial ablation between 2012 and 2023 in Máxima Medical Centre
  • Women had to suffer from heavy menstrual bleeding

You may not qualify if:

  • \- No saved hysteroscopy images or bad quality hysteroscopy images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Máxima MC

Veldhoven, North Brabant, 5500MB, Netherlands

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Marlies M.Y. Bongers, PhD, MD

    Maxima Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical student

Study Record Dates

First Submitted

November 5, 2023

First Posted

November 8, 2023

Study Start

March 1, 2023

Primary Completion

August 1, 2025

Study Completion

December 30, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations

NL(1)