Dysfunctional Uterine BleedingPhase 4NCT01173965
Endometrial Ablation With Non-hysteroscopic Methods
A Phase 4 study testing MEA and Novasure in people with Dysfunctional Uterine Bleeding, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women only
- Conditions the study is for
- Dysfunctional Uterine Bleeding
- What is being tested?
- MEA and Novasure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesGreece
- Study dates
- Jan 2008to Feb 2011
- Phase
- Phase 4
- 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 30 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing)
Who cannot join
- Endometrial pathology
- FSH > 20 day 2 -day 3 of the cycle
- Clotting Disorders
- Thyroid Dysfunction
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital
Thessaloniki, Thessaloniki, 56403
First Dept. of ObGyn, Medical School, Aristotle University of Thessaloniki, Papageorgiou Hospital
Thessaloniki, Thessaloniki, 56403
About this study
Official title: Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)
Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- MEA, Novasure
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEADevice
Also called Microwaves (MEA®)
Microwave endometrial ablation device
NovasureDevice
Also called Bipolar Impedance Control System (Novasure®)
Bipolar impedence control system
| Study group | Role | What they receive |
|---|---|---|
| Endometrial ablation with microwaves | Active comparator | Endometrial ablation with the use of MEA(microwaves endometrial ablation device) Receives: Device: MEA |
| Endometrial ablation with bipolar diathermy | Active comparator | Endometrial ablation with Novasure(bipolar impedence control system) Receives: Device: Novasure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amenorrhoea rates one year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173965
- Sponsor's protocol ID
- 3873
- Status last verified
- Sep 2009
- First submitted
- 2 Aug 2010
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)
- ClinicalTrials.gov ID
- NCT01173965
- Acronym / sponsor ID
- 3873
- Conditions
- Dysfunctional Uterine Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Aug 2010 (estimated)
- 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.
Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial ablation with microwaves | Active comparator | Device: MEAEndometrial ablation with the use of MEA(microwaves endometrial ablation device) |
| Endometrial ablation with bipolar diathermy | Active comparator | Device: NovasureEndometrial ablation with Novasure(bipolar impedence control system) |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing)
Key exclusion criteria (4 listed)
- Endometrial pathology
- FSH > 20 day 2 -day 3 of the cycle
- Clotting Disorders
- Thyroid Dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEAAlso: Microwaves (MEA®)Microwave endometrial ablation device | Device | Endometrial ablation with microwaves |
| NovasureAlso: Bipolar Impedance Control System (Novasure®)Bipolar impedence control system | Device | Endometrial ablation with bipolar diathermy |
Primary outcome
Amenorrhoea rates one year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MEA and Novasure in people with Dysfunctional Uterine Bleeding, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
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 4 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: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amenorrhoea rates one year after intervention. 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 12 Jul 2012.