Clinical Performance and Safety of Cerviron® Vaginal Ovules in the Management of Symptomatic Cervical Lesions: A National, Multicentric Study

Background

Cervical ectropion is frequently associated with vaginal symptoms requiring therapeutic intervention. However, no scientific consensus has been reached regarding the use of local re-epithelialization therapy to prevent severe bleeding, wound inflammation, and infection of cervical lesions.

Objective

The aim of our study was to investigate the aspect of the cervix by colposcopy after a 3-month treatment with an intravaginal medical device in the context of postoperative care of the symptomatic ectropion. The study analyzed additional clinical parameters, such as the evolution of primary and secondary inflammation and the degree of cervical epithelialization as secondary objectives.

Methods

Our pilot study included 27 participants with symptomatic cervical ectopy, with or without an associated human papillomavirus infection. The treatment protocol consisted of the monthly delivery of the medical device intravaginally, during day 1 to day 15, with a total study duration of 3 months.

Results

The medical device had a positive impact on cervical epithelialization, in terms of aspect of the cervix returning to normal for 100% of the participants. Between study visits, it was observed that primary inflammation was reduced by 85.19%, whereas vaginal ulceration, colpitis, and leukorrhea were improved by 70.37%, 81.48%, and by 66.67%, respectively.

Conclusions

The degree of cervical epithelialization reflects how well the cervix has healed after an injury or infection. The device showed clinical performance in complete re-epithelialization after surgical procedures. Moreover, our study findings suggest that supportive treatment with this intravaginal medical device can be recommended for cervical wound healing in patients with human papillomavirus infection. ClinicalTrials.gov identifier: NCT04735718.