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COMPLETED
NCT03429582
NA

Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

The purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. 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.

Official title: Comparison of Cervical Intraepithelial Neoplasia 2/3 Treatment Outcomes With a Portable LMIC-adapted Thermal Ablation Device vs. Gas-based Cryotherapy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1154

Start Date

2020-10-30

Completion Date

2025-07-01

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DEVICE

Standard C02 Cryotherapy

Standard therapy using carbon dioxide for freezing of tissue

DEVICE

Single Tip Thermoablation

Thermoablator outfitted with a 19mm conical tip

DEVICE

Multiple Tip Thermoablation

Thermoablator outfitted with detachable probes

Locations (2)

Peking University Shenzhen Hospital

Shenzhen, China

Hospital Nacional de la Mujer

San Salvador, El Salvador