Cavaterm™ SystemCAVATERMNCT07205146
CavatermTM for Idiopathic Functional Menometrorraghia
An observational study of Cavaterm™ System, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The prevalence of menometrorrhagia is estimated at 11% to 13% in the general population and increases with age to reach 24% in 36-40 year olds. It is the leading cause of gynecological consultations. Considered benign, menometrorrhagia is responsible for anemia and impaired quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cavaterm™ System
- What is being tested?
- menometrorrhagia
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2025to 1 Aug 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study includes all patients who received treatment with the Cavaterm™ system for idiopathic functional menometrorrhagia between January 2024 and December 2024.
Who may be able to join
- women over 18
- patient who benefited from treatment with the Cavaterm™ system for idiopathic functional menometrorrhagia
- treatment between January 2024 and December 2024
- person having expressed his non-opposition
Who cannot join
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Symptoms After Treatment With System CavatermTM for Idiopathic Functional Menometrorraghia Contraceptive Implants
The prevalence of menometrorrhagia is estimated at 11% to 13% in the general population and increases with age to reach 24% in 36-40 year olds. It is the leading cause of gynecological consultations. Considered benign, menometrorrhagia is responsible for anemia and impaired quality of life. It is the most common cause of iron deficiency anemia in premenopausal women.
The etiology of menometrorrhagia is varied. The main causes of menometrorrhagia are organic causes, iatrogenic causes, coagulopathies, hypothyroidism, and endometrial atrophy. In the majority of cases, no underlying pathology is found; they are then called functional idiopathic. This is a diagnosis of exclusion.
Read more
In idiopathic functional menometrorrhagia, the first-line treatment is medical. In the event of failure of medical treatment (in 50% of cases), in women who do not wish to maintain their reproductive possibilities, surgical treatment may be considered.
The Cavaterm™ system is a balloon-assisted endometrial ablation device. Treatment with Cavaterm™ involves removing the endometrium using a minimally invasive technique. The procedure is short-term and outpatient.
In this study, we aim to evaluate the Cavaterm™ system for the treatment of idiopathic functional menometrorrhagia.
- Conditions
- Cavaterm™ System
- Being tested
- menometrorrhagia
- Keywords
- Cavaterm™ system, idiopathic functional menometrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menometrorrhagiaOther
rate of menometrorrhagia at 2 months after treatment
| Study group | Role | What they receive |
|---|---|---|
| Cavaterm | patients who received treatment with the Cavaterm™ system for idiopathic functional menometrorrhagia Receives: Other: menometrorrhagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
menometrorrhagia
rate of menometrorrhagia at 2 months after treatment
Measured: at 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavaterm™ SystemStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205146
- Sponsor's protocol ID
- 25-5206
- Acronym
- CAVATERM
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Symptoms After Treatment With System CavatermTM for Idiopathic Functional Menometrorraghia Contraceptive Implants
- ClinicalTrials.gov ID
- NCT07205146
- Acronym / sponsor ID
- CAVATERM / 25-5206
- Conditions
- Cavaterm™ System
- Keywords
- Cavaterm™ system, idiopathic functional menometrorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 3 Oct 2025 (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.
The prevalence of menometrorrhagia is estimated at 11% to 13% in the general population and increases with age to reach 24% in 36-40 year olds. It is the leading cause of gynecological consultations. Considered benign, menometrorrhagia is responsible for anemia and impaired quality of life. It is the most common cause of iron deficiency anemia in premenopausal women.
The etiology of menometrorrhagia is varied. The main causes of menometrorrhagia are organic causes, iatrogenic causes, coagulopathies, hypothyroidism, and endometrial atrophy. In the majority of cases, no underlying pathology is found; they are then called functional idiopathic. This is a diagnosis of exclusion.
In idiopathic functional menometrorrhagia, the first-line treatment is medical. In the event of failure of medical treatment (in 50% of cases), in women who do not wish to maintain their reproductive possibilities, surgical treatment may be considered.
The Cavaterm™ system is a balloon-assisted endometrial ablation device. Treatment with Cavaterm™ involves removing the endometrium using a minimally invasive technique. The procedure is short-term and outpatient.
In this study, we aim to evaluate the Cavaterm™ system for the treatment of idiopathic functional menometrorrhagia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cavaterm | – | Other: menometrorrhagiapatients who received treatment with the Cavaterm™ system for idiopathic functional menometrorrhagia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes all patients who received treatment with the Cavaterm™ system for idiopathic functional menometrorrhagia between January 2024 and December 2024.
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| menometrorrhagiarate of menometrorrhagia at 2 months after treatment | Other | Cavaterm |
Primary outcome
menometrorrhagia
Time frame: at 2 months after treatment
rate of menometrorrhagia at 2 months after treatment
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 3 Oct 2025.
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 Cavaterm™ System, run by Hospices Civils de Lyon at 1 site in France.
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 4 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 3 Oct 2025. 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 France. 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?
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?
menometrorrhagia (time frame: at 2 months after treatment). 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 3 Oct 2025.