NCT02956239

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,124

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

4.5 years

First QC Date

September 6, 2016

Last Update Submit

July 5, 2024

Conditions

Cervical Precancer

Keywords

cervical precancerscreeningtreatmentthermo-coagulationthermal ablationReducing overtreatment

Outcome Measures

Primary Outcomes (1)

  • Difference in proportions with no lesions at 12 months follow-up between the thermocoagulation and cryotherapy arms among VIA positive women treated at baseline

    The VIA positive women will be followed up after 12 months to see if the lesions have disappeared. HPV test will be used as the test of cure

    12 months

Secondary Outcomes (1)

  • Over-treatment defined as the number of VIA positive women found with no CIN lesions in the post-operative LEEP specimens

    12 months

Study Arms (3)

Thermocoagulation (device)

EXPERIMENTAL

VIA Positive women will be treated by the new device for thermocoagulation

Procedure: Thermocoagulation (device)

Cryotherapy (device)

ACTIVE COMPARATOR

VIA positive women will be treated by cryotherapy

Procedure: Cryotherapy (device)

LEEP (device)

ACTIVE COMPARATOR

VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP

Procedure: LEEP (device)

Interventions

Thermocoagulation (device)PROCEDURE

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

Thermocoagulation (device)
Cryotherapy (device)PROCEDURE

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

Cryotherapy (device)
LEEP (device)PROCEDURE

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

LEEP (device)

Eligibility Criteria

Age25 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive on VIA test for cervical cancer screening
  • Eligible for ablative treatment

You may not qualify if:

  • Pregnancy
  • Not voluntarily willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Global Project Zambia

Lusaka, Zambia

Location

Related Publications (3)

  • Pinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, Sauvaget C, Mwanahamuntu MH, Sankaranarayanan R, Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2020 Jan;21(1):175-184. doi: 10.1016/S1470-2045(19)30635-7. Epub 2019 Nov 14.

    PMID: 31734069BACKGROUND

  • Mwanahamuntu M, Kapambwe S, Pinder LF, Matambo J, Chirwa S, Chisele S, Basu P, Prendiville W, Sankaranarayanan R, Parham GP. The use of thermal ablation in diverse cervical cancer "screen-and-treat" service platforms in Zambia. Int J Gynaecol Obstet. 2022 Apr;157(1):85-89. doi: 10.1002/ijgo.13808. Epub 2021 Jul 31.

    PMID: 34197624BACKGROUND

  • Basu P, Mwanahamuntu M, Pinder LF, Muwonge R, Lucas E, Nyambe N, Chisele S, Shibemba AL, Sauvaget C, Sankaranarayanan R, Prendiville W, Parham GP. A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial. Nat Med. 2024 Sep;30(9):2596-2604. doi: 10.1038/s41591-024-03080-w. Epub 2024 Jun 25.

    PMID: 38918630BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

ElectrocoagulationCryotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Partha Basu, Dr

    IARC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Early Detection, Prevention and Infection Branch at IARC, WHO

Study Record Dates

First Submitted

September 6, 2016

First Posted

November 7, 2016

Study Start

August 1, 2017

Primary Completion

February 16, 2022

Study Completion

February 29, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Locations

ZA(1)