D25
Conditions
Interventions
Group 1: transcervical fibroid ablation using the Sonata-System
Group 2: standard laparoscopic myomectomy
Sponsors
Forschungsinstitut für Frauengesundheit
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following conditions may be included: - Written informed consent - Women who are = 18 and = 50 years old - Have symptomatic uterine fibroids including heavy menstrual bleeding - Are seeking a uterus-preserving fibroid treatment - For whom TFA treatment with Sonata is deemed appropriate by their treating physicians - For whom fibroid treatment with laparoscopic myomectomy with OR without adjunct hysteroscopic myomectomy is appropriate - Have up to 10 non-pedunculated fibroids that are <8cm
Exclusion criteria
Exclusion criteria: - contraindicated for either TFA or laparoscopic myomectomy - in the opinion of the treating physician, the subject is not appropriate or suitable to participate in the trial (e.g., anovulation, adenomyosis, immunocompromised, woman who are pregnant or breast feeding)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the trial is to determine if Return to Normal Activity (RTNA) following TFA is shorter than that following a myomectomy procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| procedure duration and details length of stay vitals and procedure recovery pain score during hospitalization and at discharge pain medications through 30 days as an indicator for procedure recovery number, maximal diameter, location, and type of fibroids treated time (days) to return to work, resume normal bowel movements, resumption of normal urinary function, resumption of a normal diet intraoperative, 30-day and 1-year serious device/procedure related adverse events (AEs) 6- and 12-month symptom severity score (SSS) and health-related quality of life outcomes (HRQL) using the Uterine Fibroid System and Quality of Life (UFS-QoL) questionnaire 6- and 12-month overall treatment effect (OTE) and subject satisfaction (OTE Subject Satisfaction Questionnaires) pregnancy occurrence and outcome relevant surgical reinterventions | — |
Countries
Germany
Contacts
Public ContactSara Brucker
Forschungsinstitut für Frauengesundheit
Outcome results
None listed