On October 1, 2025, Yale University announced an exciting next step in clinical research with a randomized controlled trial (RCT) investigating the use of a Cervical Ripening Double Balloon (CRDB) Catheter prior to dilation and evacuation procedures. This study, listed on ClinicalTrials.gov, aims to explore the effectiveness and safety of the CRDB catheter compared to conventional osmotic dilators in cervical preparation. Currently, the trial has not yet started recruiting participants.
In this article:
- What is this clinical trial investigating?
- Why is cervical preparation important?
- What are the potential regulatory and clinical implications?
- FAQs
- Conclusion
- Disclaimer
- Announcement link
What is this clinical trial investigating?
This randomized controlled trial focuses on comparing two devices for cervical preparation in dilation and evacuation procedures: the Cervical Ripening Double Balloon (CRDB) catheter and traditional osmotic dilators. Both devices are intended to soften and dilate the cervix, minimizing trauma during the procedure.
The study aims to evaluate procedural efficiency, patient safety, and device effectiveness. The trial, funded and led by Yale University, remains in the planning stage and has not yet initiated participant recruitment.
Why is cervical preparation important?
Cervical preparation is a critical step in dilation and evacuation, which is commonly performed for second-trimester pregnancy termination or miscarriage management. Adequate preparation reduces procedure-related risks, including uterine injury and cervical laceration.
Osmotic dilators work by absorbing moisture and expanding over time, mechanically dilating the cervix. In contrast, the CRDB catheter employs a different mechanism: two inflatable balloons apply localized pressure to induce dilation while maintaining patient safety and comfort.
What are the potential regulatory and clinical implications?
The outcomes of this RCT could impact regulatory pathways and clinical practices. If the CRDB catheter demonstrates superior performance and safety, it may influence device approvals and evidence-based guidelines for cervical preparation.
Furthermore, the trial results could provide manufacturers with key data for submission under regulations like the EU MDR Annex XIV, emphasizing safety, intended performance, and benefit-risk evaluations.
From a clinical standpoint, the trial holds the potential to improve patient outcomes and practitioner confidence in adopting innovative devices for reproductive care.
FAQ
1. When is this study expected to start?
Recruitment has not yet begun, and an official start date has not been announced.
2. Who can participate in this trial?
Eligibility criteria will be outlined on the study’s ClinicalTrials.gov page once recruitment starts.
3. Where will the study take place?
The trial is sponsored by Yale University. Further site locations have not been disclosed yet.
Conclusion
This upcoming clinical trial is a significant step in advancing cervical preparation technology. With Yale University’s sponsorship and commitment to rigorous investigation, findings may pave the way for safer and more effective methods in reproductive health procedures.
Disclaimer
This article is for informational purposes only and does not constitute legal or clinical advice. Always consult regulatory and clinical professionals for specific guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07200115?term=medical+device