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CavatermTM for Idiopathic Functional Menometrorraghia (CAVATERM)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Cavaterm™ System

Treatments

Other: menometrorrhagia

Study type

Observational

Funder types

Other

Identifiers

NCT07205146
25-5206

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Inclusion Criteria * :

    • 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
  • Exclusion Criteria * :

    • inability to understand the information given
    • person deprived of liberty
    • person under guardianship

Trial design

20 participants in 1 patient group

Cavaterm
Description:
patients who received treatment with the Cavaterm™ system for idiopathic functional menometrorrhagia
Treatment:
Other: menometrorrhagia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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