Medical device

Valéb, a novel and superior method to treat cervical precancer

Cervical cancer and precancerous cervical changes remain significant in global health, necessitating effective screening and intervention strategies. However, the current standard procedure, large loop excision of the transformation zone (LLETZ) or cone biopsy has inherent limitations.

Dr. Dirk Coeman invented a novel and superior method to treat cervical precancer: Vacuum-Assisted Loop Excisional Biopsy (VALÉB). This study introduces the VALÉB as device as a minimally invasive alternative with potential advantages over LLETZ. The device will enable a minimally invasive approach that will revolutionize cervical precancer to improve women’s health and becoming a new golden standard to treat cervical precancer.

Building upon the shortcomings of LLETZ, the Valéb device features a cup-shaped apparatus that employs a vacuum mechanism for cervix aspiration and stabilization. The automated clockwise rotation of an electrical wire within the cup enables precise and controlled electrical tissue excision. Acting into a cup thus preventing surgical smoke. Valéb addresses a key concern associated with LLETZ enhancing patient and staff safety.

The Valéb device offers distinct advantages including a significant reduction in the excised volume of mainly healthy cervix while achieving comparable clinical outcomes. Additionally, its adjustable excision depth in the endocervix offers a tailored approach to individual patient needs. The potential impact of the Valéb device extends to both high-income countries (HICs) as well as low- and middle-income countries (LMICs). In LMICs, where trained paramedics play a vital role in healthcare delivery. Here Valéb offers opportunities for improving access to excisional biopsy procedures. In HICs, Valéb is performed by trained gynecologists. It potentially reduces early and long-term complications. Moreover, it is a standardized procedure demanding a minor learning curve.

To evaluate the safety, efficacy, and feasibility of the Valéb device, comprehensive clinical trials are warranted/needed. Future research should focus on conducting well-designed studies with rigorous methodologies to assess patient outcomes, compare the device with existing techniques, and determine cost-effectiveness. Prospective studies involving diverse patient populations and long-term follow-up are essential to validate Valéb’s performance and assess its impact on reducing cervical cancer incidence and improving overall women’s health.

By addressing the limitations of cone biopsy and introducing innovative features, the Valéb aims to become the new gold standard in the management of cervical dysplasia. Further research and clinical trials will shed light on its full potential, ultimately contributing to the prevention, early detection, and treatment of cervical precancerous lesions.

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