duration, flow outside of normal volume or frequency regularity
Conditions
Interventions
For each patient, a total of 6 visits (5 on-site and 1 remote) will be planned.
Unscheduled visit(s) will be planned on-site according to Principal 
Investigator judgement.
Each Subject, after signing the Informed Consent Form (ICF), will enter a 
screening phase (V-1) during which several assessments (e.g., demographics, 
medical history, current menstrual condition, blood analysis) will be 
conducted. 
At the screening visit, patients will receive a menstrual calendar and a PBAC 
to be completed. The PBAC score must be recorded as soon as available to 
confirm that the patient can be enrolled at baseline (PBAC must be >
=150). The 
PBAC score will also be recorded at the End of Study (EOS) visit. 
At baseline (V0) and at EOS, on site,  
patients will also complete the Menorrhagia Impact 
Questionnaire (MIQ). If the Investigator can complete all the assessments foreseen at baseline visit (V0) and V1-EA in one day, V0 and V1 may coincide.
At V1, enrolled Subjects will undergo EA with t
within 15-20 days from the beginning of the menstrual cycle. EA cannot be 
performed in the presence of heavy menstrual bleeding, but it can be performed 
in the presence of light bleeding/spotting. 
Sedation will be performed before the EA by intravenous administration of 
propofol and fentanyl. 
The duration (seconds) of the ablation cycle will be recorded on the CRF. After 
the procedure is completed, the PI will fill a questionnaire on procedural ease 
Sponsors
Aqua Therapeutics, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed patient informed consent form (ICF). 2. Females aged >= 30 years and =150 at baseline. 6. Normal endometrial biopsy. 7. Negative PAP test. 8. Willingness to follow all study procedures, including attending all site visits, tests, and examinations.
Exclusion criteria
Exclusion criteria: 1. BMI >=35 2. Postmenopausal status. 3. Undiagnosed vaginal bleeding. 4. A patient with a history of a prior completed endometrial ablation procedure and/or endometrial resection (including endometrial ablation/resection performed immediately prior to the ATTTVAS Ablation Treatment) regardless of the modality by which it was performed. 5. Previous uterine surgery. 6. Uterine cavity-length <4 cm or >6 cm (without cervix length). 7. Not willing to avoid the use of vaginal ring, hormonal intrauterine device (concomitant IUD such as Essure is not allowed prior to the ATTTVAS Ablation Treatment), oral contraceptives during the study period. 8. Pregnant or breastfeeding. 9. Less than 1-year post-partum. 10. Any contraindication to endometrial ablation. 11. History of previous classical cesarean section or transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the ATTTVAS Ablation Treatment. 12. Confirmed pelvic inflammatory disease, active/acute endometritis, sexually transmitted disease, bacteremia, sepsis, other active local and/or systemic infection. 13. Active genital or urinary tract infection (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis) at the time of treatment. 14. Congenital malformation of the uterus, fibroid(s) distorting the uterine cavity, or large (> 1 cm) endometrial polyp(s). 15. Congenital malformations of the female genital tract. 16. Subjects with suspected or known coagulopathies or receiving anticoagulation therapy. 17. A patient currently on medications that could thin the myometrial muscle, such as long-term steroid use (except for inhaler or nasal therapy for asthma). 18. Documented cervical dysplasia, complex or atypical endometrial hyperplasia, abdominal or pelvic cancer. 19. Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study. 20. Presence of any relevant severe organic, systemic, or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant in Investigator*s opinion. 21. Active malignant neoplasm of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable). 22. Participation in another investigational study within the previous 30 days. 23. Recent history or suspicion of alcohol abuse or drug addiction. 24. Inability to follow study procedures. 25. History of allergic reactions to propofol and/or fentanyl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS), the incidence of device-related complications will be assessed up to the end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints 1. To evaluate the change of menstrual blood loss (MBL), the pictorial blood loss assessment chart (PBAC) score will be assessed at baseline and at End of Study (EOS) visit. 2. To evaluate the effect of MBL on the quality of life (QoL), the Menorrhagia Impact Questionnaire (MIQ) will be completed by the patient at baseline and at EOS. 3. To evaluate pain intensity after treatment, a Numeric Rating Scale (NRS) * with 0 representing no pain and 10 representing unbearable pain * will be used, at discharge, after 24 hours and after 1 week from discharge. 4. To evaluate the procedural ease of use, a questionnaire will be completed by the Investigator on the day of treatment. 5. To monitor menstrual changes (menstrual frequency, duration, regularity), a menstrual calendar will be used by the patient from V-1 to EOS. 6. To evaluate the need for surgical or medical intervention to treat AUB after EA with the ATTTVAS, any surgical or medical intervention required to treat AUB after EA will be recorded. 7. To evaluate patient*s satisfaction with the ATTTVAS, a 5-Likert Scale will be used at discharge and at EOS. 8. To evaluate PI*s satisfaction with the ATTTVAS, a 5-Likert Scale will be used at discharge and at EOS. Safety Endpoints 9. Monitoring of clinical parameters and vital signs over the duration of the study. 10. Monitoring of device deficiencies before, during and after the use of the device. 11. Monitoring of adverse events and serious adverse events unrelated to study device over the duration of the study. 12. Monitoring of concomitant medications over the duration of the study. | — |
Countries
Italy, Netherlands
Contacts
Public ContactValentina Galimberti
1 MED SA
Outcome results
None listed