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NCT05299801: DAMIEN
DAta MIning to Evaluate Novasure Treatment
trial in Abnormal Uterine Bleeding in 1,038 participants. Status unknown.
1 July 2024
Quick facts
| Lead sponsor | Maxima Medical Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,038 |
| Start date | 1 July 2021 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across Netherlands |
Conditions studied
- Abnormal Uterine Bleeding — all drugs for Abnormal Uterine Bleeding →
Sponsor
Maxima Medical Center
Who can join
Eligibility, female only, with Abnormal Uterine Bleeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05299801
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Abnormal Uterine Bleeding
Currently open trials in the same condition.
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- NCT07496905 — The Effect of the Valsalva Maneuver in Endometrial Biopsy: A Randomized Controlled Trial · NA · recruiting
- NCT07169214 — Evaluation of Safety, Efficacy, and Pharmacokinetics of BT-114143 Injection in Patients With Abnormal Uterine Bleeding · Phase 1 · recruiting
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Other Maxima Medical Center trials
Trials by the same sponsor.
- NCT07422181 — PlaCEUS: Feasibility Study of Contrast-enhanced Ultrasound to Visualize Maternal Uterine Spiral Arteries Postpartum. · NA · recruiting
- NCT07077109 — Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise · NA · not yet recruiting
- NCT07061366 — The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study. · recruiting
- NCT07152106 — Amniotic Fluid & the Preterm Gut · recruiting
- NCT06392178 — SugarVita: a Digital Board Game · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05299801 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maxima Medical Center
- Last refreshed: 29 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05299801.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing