Geneva, March 23 -- International Clinical Trials Registry received information related to the study (ISRCTN67368981) titled 'Cervical preparation with a balloon device' on March 11.
Study Type: Interventional
Study Design:
Allocation: N/A: single arm study
Masking: Open (masking not used)
Control: Uncontrolled
Assignment: Single
Purpose: Device feasibility
Primary Sponsor: Medicines360
Condition:
Need for cervical dilation prior to second-trimester uterine procedures
Pregnancy and Childbirth
Intervention:
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 infor...