CavatermTM for Idiopathic Functional Menometrorraghia
- Conditions
- Cavaterm™ System
- Registration Number
- NCT07205146
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method menometrorrhagia at 2 months after treatment rate of menometrorrhagia at 2 months after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital Femme Mère Enfant
🇫🇷Lyon, France
Hôpital Femme Mère Enfant🇫🇷Lyon, France