MenorrhagiaPhase 4NCT01436903
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
A Phase 4 study testing Thermal Balloon Endometrial Ablation in people with Menorrhagia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Thermal Balloon Endometrial Ablation
- Type of treatment
- Medical device
- How many people
- 290 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2010to Apr 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- CavatermTM operation because of menorrhagia
- timeframe: January 2006 till August 2009
- older than 29 years and younger than 56 years
Who cannot join
- pregnancy
- fragmentary filled questionnaire
- more than 1 CavatermTM operation
Trial locations and contacts
1 site in 1 country.
Austria1 site
Landesklinikum Thermenregion Neunkirchen
Neunkirchen, Lower Austria, 2620
About this study
Official title: Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients
CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.
- Conditions
- Menorrhagia
- Being tested
- Thermal Balloon Endometrial Ablation
- Keywords
- menorrhagia, dysfunctional uterine bleeding, endometrial ablation, cavatermTM, probe
- Medical subject headings
- Menorrhagia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Balloon Endometrial AblationDevice
Also called CavatermTM
Thermal Balloon Endometrial Ablation for 10 minutes after curettage
What is being measured
The primary outcome is the main question the study is designed to answer.
Postsurgical change in bleeding patterns dependent on cavum probe length.
Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.
Measured: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Postsurgical change in patient satisfaction dependent on cavum probe length.
The questionnaire will ask for satisfaction and recommendation to the best friend.
Measured: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Secondary outcomes (4)
Postsurgical change in dyspareunia
The questionnaire will ask for pre- and postsurgical dyspareunia.
Measured: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Postsurgical change in Premenstrual Syndrome
The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.
Measured: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Prevention of further gynaecological therapies
The questionnaire will ask for postsurgical hysterectomy and further medications.
Measured: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Improvement of quality of life
The questionnaire will ask for postsurgical quality of life.
Measured: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beda Hartmann, Medical University of Vienna
- Investigators
- Beda W. Hartmann, Univ.-Doz., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436903
- Sponsor's protocol ID
- 743/2010
- Status last verified
- Mar 2013
- First submitted
- 12 Aug 2011
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients
- ClinicalTrials.gov ID
- NCT01436903
- Acronym / sponsor ID
- 743/2010
- Conditions
- Menorrhagia
- Keywords
- menorrhagia, dysfunctional uterine bleeding, endometrial ablation, cavatermTM, probe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Sep 2011 (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.
CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- CavatermTM operation because of menorrhagia
- timeframe: January 2006 till August 2009
- older than 29 years and younger than 56 years
Key exclusion criteria (3 listed)
- pregnancy
- fragmentary filled questionnaire
- more than 1 CavatermTM operation
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 |
|---|---|---|
| Thermal Balloon Endometrial AblationAlso: CavatermTMThermal Balloon Endometrial Ablation for 10 minutes after curettage | Device | – |
Primary outcome
Postsurgical change in bleeding patterns dependent on cavum probe length.
Time frame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.
Postsurgical change in patient satisfaction dependent on cavum probe length.
Time frame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
The questionnaire will ask for satisfaction and recommendation to the best friend.
4 secondary outcomes
Postsurgical change in dyspareunia
Time frame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Postsurgical change in Premenstrual Syndrome
Time frame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Prevention of further gynaecological therapies
Time frame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Improvement of quality of life
Time frame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
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 8 Mar 2013.
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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.
Beda W. Hartmann, Univ.-Doz. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thermal Balloon Endometrial Ablation in people with Menorrhagia, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 3 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 8 Mar 2013. 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 Austria. 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?
Postsurgical change in bleeding patterns dependent on cavum probe length. (time frame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.). The study lists 2 primary outcomes in all. 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 8 Mar 2013.