heavy menstrual bleeding
Conditions
Interventions
Novasure Global endometrial ablation
Thermablate endometrial ablation
Sponsors
Máxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Refractory menorraghia ;Uterine sound measurement of 6.0 - 12 cm ;Failed, contraindicated or intolerance to conservative therapy. ;Menstrual Diary A minimum score of >150 for 1 months ;Willing to undergo the treatment under local anesthesia in the outpatient clinic
Exclusion criteria
Exclusion criteria: 3.2.2.1 Presence of bacteremia, sepsis, or other active systemic infection;3.2.2.2 Active or recurrent chronic pelvic inflammatory disease ;3.2.2.3 Prior uterine surgery (except low segment cesarean section) which interrupts the integrity of the uterine wall e.g., transmural myomectomy or classical cesarean section. Prior endometrial ablations.;3.2.2.4 Desire to preserve fertility ;3.2.2.5 Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) ;3.2.2.6 Suspected or confirmed uterine malignancy or confirmed uterine malignancy within the last five years as confirmed by histology );3.2.2.7 Endometrial hyperplasia as confirmed by histology ;3.2.2.8 Unaddressed cervical dysplasia;3.2.2.9 Elevated FSH levels consistent with ovarian failure ( > 40 IU/ml) ;3.2.2.10 Active sexually transmitted disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective Evaluate the effectiveness of Device procedure compared to in achieving amenorrhea at twelve months post-treatment for menorrhagia secondary to DUB | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate and compare pain and acceptability scores of the hot fluid balloon ablation (Thermablate) procedure and the Novasure Endometrial Ablation procedure as an outpatient treatment. | — |
Countries
Netherlands
Outcome results
None listed