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OpenTrials
Completed

NCT Number: NCT07205146

CavatermTM for Idiopathic Functional Menometrorraghia

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Femme Mère Enfant

Lyon, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

menometrorrhagia

Other

rate of menometrorrhagia at 2 months after treatment

Primary outcomes

  1. menometrorrhagia

    Time frame: at 2 months after treatment

    rate of menometrorrhagia at 2 months after treatment

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evolution of Symptoms After Treatment With System CavatermTM for Idiopathic Functional Menometrorraghia Contraceptive Implants

Acronym: CAVATERM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.