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

NCT03429582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1154

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

  • Cervical Intraepithelial Neoplasia

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Basic Health International

    collaborator OTHER

  • WISAP Medical Technologies GMBH

    collaborator UNKNOWN

  • University of Southern California

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Miriam Cremer, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2025-03-30
Completion
2025-07-01

Countries

  • China
  • El Salvador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03429582 on ClinicalTrials.gov