Feasibility study for use of a balloon cervical dilator for cervical dilation prior to uterine evacuation
Need for cervical dilation prior to second-trimester uterine procedures
This is an open-label, single-arm feasibility study of a 14 mm intracervical balloon radial dilation device (M360-CDD-001-14) in participants at 13–16 weeks’ gestation planning a second-trimester uterine procedure. After informed consent, the device is placed within the cervical canal following cervical preparation, and local anesthesia; intravenous sedation is provided per site standard of care. The balloon is inflated with sterile water and then deflated and removed. Cervical dilation is assessed after balloon removal. The planned procedure then proceeds using standard clinical practice; if dilation is inadequate or not tolerated, standard cervical preparation methods are used. Treatment consists of a single procedural episode, with a safety follow-up contact 3–7 days after device use. There is no randomization or control group.
1. Signed informed study consent 2. Healthy females 18 years old or more at the time of enrollment 3. Unwanted pregnancy or fetal demise at 13 0/7 to 16 0/7 weeks gestation/gestational size 4. Desiring uterine evacuation and signed procedure consent before signing study informedconsent 5. BMI <40.0 kg/m^2 6. English speakers and readers
1. Prior failed uterine evacuation attempt in the current pregnancy 2. Known cervical stenosis 3. Coagulopathy or current use of anticoagulants 4. Use of misoprostol within 48 hours prior to enrollment 5. Study staff or a member of the immediate family of a study staff 6. Any condition or circumstance that, in the opinion of the Investigator, would constitute contraindications to study participation, compromise the participant’s ability to comply with the study protocol, or interfere with data collection