Miriam Cremer (United States of America)

Basic Health International Founder

Presenter of 2 Presentations

Oral Session 8: SCREENING IV. Implementation, dissemination, and communication  Hall E

PRELIMINARY RESULTS OF AN ARTIFICIAL INTELLIGENCE CLASSIFIER TO DIAGNOSE CERVICAL PRECANCER (ID 858)

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Clinical Research /Treatment of Precancer in Low-resource Settings ePoster

OPTIMIZATION OF A HANDHELD THERMAL ABLATION DEVICE FOR THE TREATMENT OF CERVICAL PRECANCER IN LOW AND MIDDLE-INCOME COUNTRIES (ID 1031)

Session Date
07/21/2020
Session Time
10:00 - 17:00
Room
ePoster
Session Type
Poster Viewing - 20-24 July
Session Name
Clinical Research /Treatment of Precancer in Low-resource Settings
Lecture Time
10:00 - 10:01

Abstract

Introduction

Thermal ablation is a potentially game-changing cervical precancer treatment that uses high temperatures to destroy lesions. However, the conventional device is not well-suited for use in limited-resource settings. We have collaborated with the manufacturer to develop a handheld model that meets the needs of low and middle-income countries (LMICs).

Methods

The C3 thermal ablator (WiSAP, Brunnthal, Germany) weighs 2lb, includes a sliding sheath to prevent vaginal burns, and operates with electricity or a rechargeable battery. The efficacy and safety of this device are being evaluated in a randomized clinical trial comparing thermal ablation to gas-based cryotherapy and a non-gas cryotherapy device. We present preliminary data on patient pain and side-effects of these treatments. Experiences from this study have been used to further optimize the device. The new model will include interchangeable probes with tips in various shapes and sizes that will be evaluated in a different, upcoming trial.

Results

The ongoing trial has randomized 566 women. Preliminary findings show that pain levels (min. =0, max.=10) are higher during thermal ablation than gas-based cryotherapy or non-gas cryotherapy (3.41 vs. 2.97 vs. 2.31, p<.004, respectively), but pain declines across arms immediately after treatment (0.11 vs. 0.41 vs. 0.38, p<.34, respectively). Cramping and vaginal discharge at 6-weeks post-treatment have been reported, respectively, by 52% and 96% of women treated with thermal ablation, 48% and 95% of women treated with gas-based cryotherapy, 43% and 88% of women treated with non-gas cryotherapy. There are no significant differences across arms (cramping = p<.72, discharge = p<.79).

Conclusions

Treatment with the C3 thermal ablator results in tolerable pain and comparable side effects to cryotherapy. An optimized device will be utilized in an upcoming randomized trial to compare single-tip and two-tip techniques against cryotherapy. Results will help standardize thermal ablation guidelines for the treatment of cervical precancer.

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