# Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy

> **NIH NIH R01** · CLEVELAND CLINIC LERNER COM-CWRU · 2020 · $897,307

## Abstract

Project Abstract
Cervical cancer is a leading cause of cancer-related mortality among women in low- and middle-income
countries (LMICs). The World Health Organization recently released guidelines that endorse alternatives to
cytology-based screening, including HPV-based screening and visual inspection with acetic acid (VIA), which
will facilitate increased screening coverage and detection of curable precursors to cervical cancer. In order to
reduce the burden of cervical cancer, highly effective screening strategies must be combined with affordable
and accessible treatment of precancerous lesions. The standard treatment for cervical precancer, gas-based
cryotherapy, is often not accessible in LMICs because gas tanks are generally expensive, difficult to obtain,
and hard to transport. With the number of screening options increasing, an urgent need exists for a point-of-
care treatment technology that is accessible, portable, and inexpensive. We innovated the original
thermoablator, an existing cervical precancer treatment device with a probe heated to 100-120º C, for use on a
wider scale by customizing the device for LMICs in order to meet this need. This academic-industrial
partnership will compare this novel device to traditional CO2-based cryotherapy for the treatment of cervical
precancer in LMICs. The Specific Aims of this project are to 1) modify a novel thermoablation prototype adapted
and optimized specifically for treatment of cervical precancer in LMICs, determine a more nearly optimal patient-
centered protocol for treatment of high-grade precancer, demonstrate that the efficacy of LMIC-adapted
thermoablator is non-inferior to CO2-based cryotherapy for the treatment of cervical precancer, and determine the
cost-effectiveness of all evaluated therapeutic and post-treatment surveillance strategies. The hypothesis being
tested is that this novel device is non-inferior to CO2-based cryotherapy in terms of clinical validity and cost-
effectiveness. The research team has well-established relationships with leading regional organizations that
provide guidance to government-run cervical cancer prevention programs. Deployment of the LMIC-adapted
thermoablator to existing programs will not only improve program efficacy, but will also serve as a model for
adoption of this technology in the region. The results of this study will affect other research areas by serving as
a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will
reach the most vulnerable populations.

## Key facts

- **NIH application ID:** 9858167
- **Project number:** 5R01CA218195-03
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** Miriam Cremer
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $897,307
- **Award type:** 5
- **Project period:** 2018-01-12 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9858167

## Citation

> US National Institutes of Health, RePORTER application 9858167, Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy (5R01CA218195-03). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9858167. Licensed CC0.

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