💬In plain words
What the trial is, and whether it could suit you
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss. Chronic AUB refers to irregularities in menstrual bleeding for most of the previous 6 months.
AUB can be frequent or infrequent, prolonged, irregular, or heavy. Heavy menstrual bleeding (HMB) is defined as "excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life". Causes of AUB are classified as polyps, adenomyosis, leiomyomas (AUB-L), malignancy and premalignant conditions, coagulopathy, ovulatory disorders (AUB-O), endometrial disorders (AUB-E), iatrogenic, and 'not classified ' . AUB affects approximately one in four women between 30 and 50 years of age, with serious implications on woman's quality of life
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
Patients will be eligible if, at screening (V-1), they will meet all of the following inclusion criteria except having a PBAC score ≥150 since this score can only be calculated at baseline visit (V0).
1. Signed patient informed consent form (ICF).
2. Females aged ≥ 30 years and ≤ 55 years at baseline with no desire to conceive, with or without simple endometrial hyperplasia (without atypia).
3. Diagnosis of AUB.
4. Premenopausal (follicle-stimulating hormone level ≤ 40 mIU/mL), women who don't want to receive hormonal treatment or who have failed to respond to hormonal treatment.
5. Pictorial Blood Loss Assessment Chart (PBAC) score ≥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. NOTE: diagnosis of AUB will include AUB history, current menstrual condition (collected at screening visit), physical examination (performed at screening and at baseline visit), blood test results (from blood samples collected at screening visit) and will be confirmed by a PBAC score ≥150 (at baseline visit).
Exclusion Criteria:
1. BMI ≥40
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. Uterine cavity-length \<4 cm or \>6 cm (without cervix length).
6. 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.
7. Pregnant or breastfeeding.\*
8. Less than 1-year post-partum.
9. Any contraindication to endometrial ablation.
10. History of previous classical cesarean section or transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the ATTTVAS Ablation Treatment.
11. Confirmed pelvic inflammatory disease, active/acute endometritis, sexually transmitted disease, bacteremia, sepsis, other active local and/or systemic infection.
12. Active genital or urinary tract infection (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis) at the time of treatment.
13. Congenital malformation of the uterus, fibroid(s) distorting the uterine cavity, or large (\> 1 cm) endometrial polyp(s).
14. Congenital malformations of the female genital tract.
15. Subjects with suspected or known coagulopathies or receiving anticoagulation therapy.
16. 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).
17. Documented cervical dysplasia, complex or atypical endometrial hyperplasia, abdominal or pelvic cancer.
18. 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, in the opinion of the Investigator may interfere with the participation to the study.
19. 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).
20. Participation in another investigational study within the previous 30 days.
21. Recent history or suspicion of alcohol abuse or drug addiction.
22. Inability to follow study procedures.
23. History of allergic reactions to propofol and/or fentanyl.
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