Minerva Endometrial Ablation System was evaluated in two clinical studies, the Minerva Single-Arm Study and the Minerva Randomized Clinical Trial. These clinical studies were conducted at seventeen medical hospitals in the United States, Canada, Mexico, and Hungary.
Doctors who conducted these clinical studies were gynecologists and treated women with heavy bleeding. The women treated with the Minerva System were from 25 to 50 years old, had heavy monthly bleeding, and did not want to have more children. All of the women were examined to see if there was a cause of their excessive menstrual bleeding and to make sure they were healthy.
The Minerva Single-Arm Study was conducted by seven doctors at different hospitals and clinics. There were 110 women included in this study. The women kept a record of their bleeding using special diary charts. They filled out the diaries for their periods before the Minerva Treatment and then completed one diary for each monthly period after the Minerva Treatment. Each diary was collected to determine the amount of bleeding before and after the Minerva Treatment. In order to be in the clinical study, the patient’s bleeding level had to be more than a certain amount. The Minerva Treatment was considered successful if a patient had a bleeding level that was normal or below normal at 12 months following the Minerva Treatment..
The women had follow-up visits with their doctor at 3 months, 6 months, and 1 year following the Minerva procedure. During these visits, the doctor examined the patients and collected their diaries to check their monthly bleeding level. The doctor also made sure all women were using birth control.
The second clinical study, the Minerva Randomized Clinical Trial, is currently in progress and involves 153 patients at 13 hospitals and clinics in three countries, including the United States. In this study, the Minerva Endometrial Ablation System is being compared to another treatment for abnormal uterine bleeding called Rollerball ablation.
In a Randomized Clinical Trial, a computer randomly assigns the patients to one of two treatment groups, either the Minerva Endometrial Ablation group or Rollerball Ablation group. A total of 153 patients are involved in this study, 102 of them were treated with the Minerva Endometrial Ablation System and 51 were treated with the Rollerball Ablation. Unlike the Minerva Single Arm Study in which women used diaries to measure bleeding levels, this study measured the patient’s bleeding before and after the treatment by collecting and testing the patient’s used sanitary products (tampons and pads). The used sanitary products were sent to a laboratory to measure the amount of blood.