Abnormal Uterine BleedingDAMIENNCT05299801
DAta MIning to Evaluate Novasure Treatment
An observational study of Abnormal Uterine Bleeding, run by Maxima Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- How many people
- 1,038 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: Women with AUB who underwent Novasure treatment for this between 2008-2018
Who may be able to join
- Women who suffer from AUB and who previously underwent Novasure treatment between 2008-2018 in MMC.
Who cannot join
- Previous Novasure for AUB.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DAta MIning to Evaluate Novasure Treatment (the DAMIEN Study): a 10-year Retrospective Single-center Cohort Study
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.
Read the detailed description
Ten-year retrospective single-center cohort study in which we will:
- retrospectively follow patients who underwent endometrial ablation using Novasure between 2009-2019 at the Máxima Medical Center and observe the incidence of outcomes and features.
- assess which patient and procedure features are associated with failure of NovaSure treatment, defined as occurrence of any subsequent invasive procedure related to AUB within 3 years, of women who underwent this treatment in Maxima MC between 2008 and 2018.
- assess which patient and procedure features are associated with a successful Novasure treatment, defined as freedom of subsequent invasive procedure within 3 years related to AUB, of women who underwent this treatment in Maxima MC between 2008 and 2018.
- develop predictive and prognostic models that assess the probability of treatment success or failure based on these patient and procedure variables.
Procedure
In this observational study, a clinical data collector will be used to review women (with automatically pseudonymised data) who had endometrial ablation with the Novasure. An overview will be given of patient and procedure features that may have played a role in the failure of the treatment. To be able to investigate this, all women who underwent the intervention at the Máxima Medical Center between 2008-2018 are included in the study. They received the usual care and did not have to follow any additional procedures.
All patients will be included in the descriptive analysis. All descriptive analyses, including total population size and follow-up time, will be given. Continuous variables are presented as mean with standard deviation, or median with interquartile range, depending on the distribution. Categorical variables are presented as number with percentage. Binary data are presented as frequency and percentage. Time between Novasure and reintervention will be given as mean (SD) and time-to-event (Kaplan-Meier). Moreover the relative risk for reintervention is calculated. In addition to classical statistical analyses, data mining (linear regression) and machine learning techniques are applied. Supervised classification models are learned to compute the importance factors of independent variables with respect to the dependent variable.
In this research only retrospective file research on pseudonymised data is carried out with outcome measures that are part of the standard quality control. All data is obtained from the Clinical data Collector. The collector extracts and pseudonymizes data from the electronic patient record. Patients are not subjected to additional actions or are not imposed to any rules of conduct for this research. There are also no questionnaires sent to patients that affect the psychological integrity or that are perceived as stressful by the test subjects.
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- endometrial ablation
- Medical subject headings
- Metrorrhagia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jul 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University
- Responsible party
- Principal investigator, Jaklien C Leemans, PhD, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299801
- Sponsor's protocol ID
- 2021-MMC-059
- Acronym
- DAMIEN
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAta MIning to Evaluate Novasure Treatment (the DAMIEN Study): a 10-year Retrospective Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT05299801
- Acronym / sponsor ID
- DAMIEN / 2021-MMC-059
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- endometrial ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Collaborators
- Utrecht University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ten-year retrospective single-center cohort study in which we will:
- retrospectively follow patients who underwent endometrial ablation using Novasure between 2009-2019 at the Máxima Medical Center and observe the incidence of outcomes and features.
- assess which patient and procedure features are associated with failure of NovaSure treatment, defined as occurrence of any subsequent invasive procedure related to AUB within 3 years, of women who underwent this treatment in Maxima MC between 2008 and 2018.
- assess which patient and procedure features are associated with a successful Novasure treatment, defined as freedom of subsequent invasive procedure within 3 years related to AUB, of women who underwent this treatment in Maxima MC between 2008 and 2018.
- develop predictive and prognostic models that assess the probability of treatment success or failure based on these patient and procedure variables.
Procedure
In this observational study, a clinical data collector will be used to review women (with automatically pseudonymised data) who had endometrial ablation with the Novasure. An overview will be given of patient and procedure features that may have played a role in the failure of the treatment. To be able to investigate this, all women who underwent the intervention at the Máxima Medical Center between 2008-2018 are included in the study. They received the usual care and did not have to follow any additional procedures.
All patients will be included in the descriptive analysis. All descriptive analyses, including total population size and follow-up time, will be given. Continuous variables are presented as mean with standard deviation, or median with interquartile range, depending on the distribution. Categorical variables are presented as number with percentage. Binary data are presented as frequency and percentage. Time between Novasure and reintervention will be given as mean (SD) and time-to-event (Kaplan-Meier). Moreover the relative risk for reintervention is calculated. In addition to classical statistical analyses, data mining (linear regression) and machine learning techniques are applied. Supervised classification models are learned to compute the importance factors of independent variables with respect to the dependent variable.
In this research only retrospective file research on pseudonymised data is carried out with outcome measures that are part of the standard quality control. All data is obtained from the Clinical data Collector. The collector extracts and pseudonymizes data from the electronic patient record. Patients are not subjected to additional actions or are not imposed to any rules of conduct for this research. There are also no questionnaires sent to patients that affect the psychological integrity or that are perceived as stressful by the test subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Women with AUB who underwent Novasure treatment for this between 2008-2018
Key inclusion criteria (1 listed)
- Women who suffer from AUB and who previously underwent Novasure treatment between 2008-2018 in MMC.
Key exclusion criteria (1 listed)
- Previous Novasure for AUB.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: 36 months
This outcome measure is recorded in the Electronic Patient File by the treating physician.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Uterine Bleeding, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.