Statement of the Problem: Every diagnostic or therapeutic gynecological procedure that requires uterine access, begins with cervical dilatation, yet current methods remain outdated and traumatic, unchanged since the 1800s. Globally, 100M women annually undergo painful cervical dilatation, with risks of perforation (1.7%), hemorrhage (6.9%), and cervical laceration (11%). Pain is the leading cause of failure in office hysteroscopy, with up to 84% of failures due to discomfort. Cervical stenosis affects 33% of women, increasing risk of failure. This underscores the urgent unmet need for safer, faster, anesthesia-free uterine access solutions.

Study Objective/Purpose: To evaluate the safety, deployment characteristics, and visualization capabilities of CerAMvix (a self-expanding nitinol cervical stent/os-finder) and CerAMvix Smart (an integrated optical dilator) using ex vivo human tissue and high-fidelity 3D models.

Methods:

A) Design: Preclinical validation study utilizing ex vivo human uterine tissue and 3D-reconstructed human cervical models (GyneSimTM) that replicate human cervical geometry and tissue elasticity.

B) Setting: Multi-center preclinical evaluation involving ten independent hospitals and private surgical centers.

C) Interventions: Surgeons performed cervical access and dilation procedures using the CerAMvix system. Performance was measured against standard surgical endpoints.

Measurements and Main Results: CerAMvix achieved successful cervical canal dilation to ≥10 mm in 100% of cases (95% CI: 72–100%). Atraumatic traversal of the cervical external os was achieved consistently without the need for traditional mechanical force. The system provided an unobstructed passageway for hysteroscopes in all trials.

The average procedure time was 7.8 minutes (95% CI: 6.9–8.7 minutes), encompassing deployment, visualization, dilation, and retrieval. Notably, there were zero device-related complications: instances of tissue tearing or cervical obstructions.

Conclusion & Significance: CerAMvix system offers a reproducible, atraumatic, and visually guided alternative to traditional mechanical dilation. By providing reliable access to the uterine cavity, this system demonstrates high potential for reducing procedural trauma while improving efficiency.

Roxana Belciu-Kerns, CEO of Amarastesia. The author brings 25+ years of clinical experience as a surgeon and Board-Certified Anesthesiologist with 15+ years spent in women’s health gynecology.