PRODUCT REVIEW: WISAP CERVICAL COAGULATOR C3

C3 THERMO-COAGULATOR

The C3 is a device for treating certain types of lesions in outpatient settings. It's made to work well in places with fewer resources. It can run on its own without needing a power grid or a lot of medical equipment. It's easy to move around, and it's simple for people to use. Even though it's easy to use, it's still as effective as the usual top-notch treatment, cryotherapy.

Thermal ablation for cervical precancerous lesions

Cervical intraepithelial neoplasia (CIN), also known as cervical dysplasia, refers to an abnormal proliferation of cells on the cervical surface. It is histologically classified as CIN1, CIN2, or CIN3. CIN2+ is primarily linked to persistent human papillomavirus (HPV) infection, especially with high-risk HPV types 16 or 18. While CIN is not cancer, akin to other intraepithelial neoplasms, it is generally treatable. However, in a small percentage of instances, untreated cases may progress to cervical cancer, typically presenting as squamous cell carcinoma of the cervix (SCC).

As per the World Health Organization, the availability of portable treatment devices facilitates convenient point-of-care treatment, reducing the risk of patient loss-to-follow-up (LTFU). Thermal ablation demonstrates effectiveness comparable to cryotherapy in treating pre-cancerous lesions. The procedure is deemed safe, with minimal side effects and adverse events, and it does not adversely affect fertility. Portable thermal ablation devices offer ease of use and management, contrasting with traditional cryotherapy machines that rely on medical gas. Consequently, several low- and middle-income countries have initiated the use of these thermal ablation devices, albeit on a small scale.

HOW DOES THERMO COAGULATION WORK?

In contrast to cryotherapy, which employs cold temperatures for tissue ablation, thermo coagulation relies on heat to eliminate tissue. Following treatment, the superficial epithelium forms blisters, and the underlying stroma and glandular crypts undergo destruction through desiccation. Thermo coagulation differs from HF coagulation, where temperatures can reach approximately 320°C. In thermo coagulation, the maximum temperature is limited to 120°C to manage post-LEEP bleeding. Specifically for treating CIN, a temperature of 100°C is utilized to ensure sufficient necrosis depth, yielding efficacy comparable to cryotherapy.

ADVANTAGES OF THERMO COAGULATION

The technology has a clinical appeal because it is user-friendly, inexpensive, and durable. The system runs entirely on electrical power and requires no gas to operate. The treatment is fast, easy to learn and the equipment has a low dependency on a service infrastructure.

The treatment requires generally no local anaesthesia and is administered within a very short treatment cycle (< 2 Minutes). The device is fairly simple to use and does not require long enduring and costly training for an operator to understand how it is done properly.

EFFICACY COMPARED TO CRYOTHERAPY

Published data shows that cold coagulation treats cervical lesions as well or better than cryotherapy. Numerous clinical trials show a parity in efficacy compared to cryotherapy, but a significant lower presence of side effects.

Who are the manufacturers?

The product is from WISAP Medical Technology GmbH, a company established in 1959 in Sauerlach, Germany, by Dr. Kurt Semm, a prominent German gynecologist recognized as the pioneer of laparoscopic surgery. WISAP continues its legacy by manufacturing instruments and devices primarily focused on gynecological laparoscopy. Their product line includes a diverse range of insufflators, suction and irrigation systems, visualization units, morcellators, as well as laparoscopic and gynecological instruments. Notably, one of the company's significant advancements is the "Cervix Coagulator," an electrothermal system designed for treating CIN 1-3.

World Health Organization and access in developing countries

The Clinton Health Access Initiative (CHAI), through an innovative grant from Unitaid to prevent deaths from cervical cancer by catalysing the use of optimal screening and treatment devices, has concluded two separate global price agreements to scale up the use of portable thermal ablation and loop electrical excision procedures (LEEP) devices in low-and-middle income countries. The two new agreements, concluded by Unitaid and CHAI with Liger Medical LCC (Liger) and Wisap Medical Technologies GmbH (Wisap) respectively, will help reduce costs and improve access to these high quality treatment technologies. As a result of these agreements, Liger and Wisap will respectively offer a price that is up to 43% and 59% lower than the current market prices for their devices. Please see pricing summary below for details. The agreements are part of an innovative project led by Unitaid and CHAI to deploy improved screening tools, introduce new portable devices for treatment, and advance easy-to-use artificial intelligence-based tools for screening of precancerous lesions. Precancerous lesions can progress to life-threatening cervical cancer if left untreated. Cervical cancer is the fourth most common cancer in women, affecting over half a million and killing more than 250,000 each year. Virtually all cervical cancers are caused by infection with human papillomavirus (HPV), a very common sexually-transmitted infection.

Some additional information

Wisap C3 SET

C3 handle

C3 Slider 20s

C3 Slider 17s

C3 Thermo Probe 20s

C3 thermo Probe 17s

Power Supply

Mains Cable

C3 Battery Pack

Cable for battery pack

Supporting stand

Carry Case

What is the status in South Africa?

Department of health issued Cervical Cancer Prevention and Control Policy in 2021 that includes guidelines on ablation use.

Covered by most major medical aids.

Available for sale in South Africa

Check www.lepekemedical.com for price guide