Non-invasive-physical-plasma treatment of low- and high-grade cervical intraepithelial neoplasia: a non-invasive and anaesthesia-independent treatment procedure evaluated in a prospective, monocentric clinical trial

Introduction Cervical intraepithelial neoplasia (CIN) are serious precursors for cervical cancer (CC) and show the highest incidence in young females. Current treatment procedures (ST) are very invasive, however, only the minority of CIN will progress into CC. Thus, over-treatment is a severe problem for affected women, health specialists and health-economy. Here, non-invasive-physical-plasma (NIPP) was evaluated as a non-invasive, painless and ambulatory treatment alternative for low- and high grade CIN lesions.

Methods In this exploratory monocentric, prospective, non-randomized clinical trial premenopausal women with CIN I/II were NIPP treated using a VIO3-APC3 device (Erbe, Tübingen) under colposcopic view and without anaesthesia. Histological follow-up was performed 3 and 6 months after NIPP treatment.

Results In this study, we determined the histopathological and cytological remission of CIN and human papilloma virus (HPV) within 6 months after single treatment with NIPP. 48 patients (mean age 29.8; 21-47) with histologically confirmed CIN I (37%) and II (63%) were included in this study. NIPP treatment was efficient to induce a sustained remission of low- and high-grade CIN (81.4% complete remission rate after 3 months, 93% sustainability after 6 months). Furthermore, NIPP treatment was accompanied with normalization of high-risk HPV (71% to 11%) and PAP smear testing.

Conclusions NIPP is an easily performable, tissue preventing, painless and ambulatory treatment procedure without the necessity of anaesthesia and hospitalization. NIPP treatment shows a high tolerability and patient satisfaction and could be an efficient and safe alternative to current standard procedures for the treatment of both low- and high-grade CIN lesions.

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Publication History

Article published online:
07 October 2020