DAta MIning to Evaluate Novasure Treatment

NCT05299801 | Unknown

• 1 other identifier: 2021-MMC-059
• Study Type: observational
• Target: 1,038
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal Uterine Bleeding (AUB) is a common health problem that affects approximately 30% of women of reproductive age and can have several underlying causes. It significantly affects quality of life, use of medical resources and health costs. Endometrial ablation is a commonly used minimally invasive surgical procedure for the treatment of AUB that destroys endometrial tissue. This procedure is an alternative treatment to hysterectomy because it is less invasive and has a shorter recovery period. Several ablation techniques are available to remove endometrial tissue, including bipolar radiofrequency (NovaSure treatment). While patient satisfaction with this form of endometrial ablation for the treatment of AUB is high, approximately 10-20% of women undergoing endometrial ablation require additional invasive surgery, primarily because of persistent blood loss or pain. There is therefore a need to identify and evaluate factors that can improve women's outcomes, or that can be building blocks for prognostic models that can be used to influence clinical practice. In this 10-year single-center retrospective cohort study, we aim to apply data mining and machine learning techniques to uncover hidden relationships/patterns between variables, and identify factors and patients at increased risk for Novasure treatment failure. With multiple time variables, this is not possible with a simple statistical analysis. Discovering these patterns and risk factors could help improve medical care, patient counseling and patient satisfaction.

Conditions

Abnormal Uterine Bleeding

Keywords

endometrial ablation

Outcome Measures

Primary Outcomes (1)

• Number of participants with Reintervention (any subsequent invasive procedure related to AUB within 3 years in Máxima MC in women who underwent Novasure treatment in 2008-2018).

  This outcome measure is recorded in the Electronic Patient File by the treating physician.

  36 months

Other Outcomes (1)

• Type of reintervention

  36 months

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with AUB who underwent Novasure treatment for this between 2008-2018

You may qualify if:

• Women who suffer from AUB and who previously underwent Novasure treatment between 2008-2018 in MMC.

You may not qualify if:

• Previous Novasure for AUB.

Sponsors & Collaborators

• Maxima Medical Center: lead
• Utrecht University: collaborator

Study Sites (1)

Máxima Medical Center

Veldhoven, Netherlands

Location

MeSH Terms

Conditions

Metrorrhagia

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 29, 2022
• Study Start: July 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

NL (1)