MedTrace Logo

Development, Field Testing and Evaluation of the Efficacy of a Hand-held, Portable and Affordable Thermo-coagulator to Prevent Cervical Cancer in Low- and Middle-income Countries

NCT02956239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3124

Last updated 2024-07-08

No results posted yet for this study

Summary

This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat programme using Visual Inspection with Acetic acid (VIA) in Sub Saharan Africa.

Conditions

  • Cervical Precancer

Interventions

PROCEDURE

Thermocoagulation (device)

Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix

PROCEDURE

Cryotherapy (device)

Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix

PROCEDURE

LEEP (device)

The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit

Sponsors & Collaborators

  • University of North Carolina Global Project Zambia

    collaborator UNKNOWN

  • Liger Medical Llc

    collaborator UNKNOWN

  • International Agency for Research on Cancer

    lead OTHER

Principal Investigators

  • Partha Basu, Dr · IARC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-02-16
Completion
2024-02-29

Countries

  • Zambia

Study Locations

More Related Trials

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 NCT02956239 on ClinicalTrials.gov