Cervical preparation with a balloon device

ISRCTN	ISRCTN67368981
DOI	https://doi.org/10.1186/ISRCTN67368981
Internal reference number	M360-CDD-P01
Sponsor	Medicines360
Funder	Medicines360

Submission date: 06/03/2026
Registration date: 11/03/2026
Last edited: 11/03/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mitch Creinin
Scientific, Public

49 Stevenson St
Suite 1100
San Francisco
94105
United States of America

Phone	+1 (0)415 951 8700
Email	mcreinin@medicines360.org

Dr Julie Thorne
Principal investigator

Women's College Hospital
Department of Gynecology
Floor 5, Office #5452
76 Grenville St
Toronto
M5S 1B2
Canada

Phone	+1 (0)416 323 7744
Email	julie.thorne@wchospital.ca

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Device feasibility
Scientific title	Feasibility study for use of a balloon cervical dilator for cervical dilation prior to uterine evacuation
Study objectives
Ethics approval(s)	Submitted 21/01/2026, Women's College Hospital REB (76 Grenville St, Toronto, M5S 1B2, Canada; +1 (0)416 351 3732 x 2723; Marie.Steele@wchospital.ca), ref: 2026-0005-E
Health condition(s) or problem(s) studied	Need for cervical dilation prior to second-trimester uterine procedures
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 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.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	M360-CDD-001-14
Primary outcome measure(s)	Successful cervical dilation measured using adequate dilation that is tolerated by the participant throughout the radial dilation process and does not require further cervical preparation (e.g., medications or rigid dilation) prior to uterine evacuation, assessed at end of study visit
Key secondary outcome measure(s)	Participant pain assessment measured using participant-reported pain assessment questions at during and immediately after device use at the enrollment visit Investigator assessment of ease of use and participant tolerance of the device measured using investigator-completed assessment questions at following completion of the cervical dilation attempt Adverse events and adverse device effects associated with balloon cervical dilation measured using clinical assessment and participant report from device use at the safety follow-up contact (3–7 days post-procedure)
Completion date	07/10/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Female
Target sample size at registration	20
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	12/05/2026
Date of final enrolment	30/09/2026

Locations

Countries of recruitment

Canada

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

11/03/2026: Study's existence confirmed by Health Canada.