NCT03429582

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

January 25, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

4.4 years

First QC Date

January 25, 2018

Last Update Submit

July 14, 2025

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Human Papilloma VirusThermoablationThermocoagulationCryotherapyCervica Pre-cancerLow and Middle Income Countries (LMICs)

Outcome Measures

Primary Outcomes (1)

  • Residual CIN2+ diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or with cervical cancer diagnosis Diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or with cervical cancer diagnosis

    To compare CIN2+ cure rates 12-months post-treatment for CO2-based cryotherapy and both single versus multiple tips thermoablation strategies

    12-months post treatment

Secondary Outcomes (1)

  • Patient's pain assessed using the Wong-Baker FACES scale

    Immediately after speculum insertion, immediately before treatment, and immediately after treatment

Other Outcomes (2)

  • Patient's satisfaction with treatment assessed with the FACIT-CD questionnaire (FACIT Measurement System)

    At enrollment, 6-week visit, and 12-month follow-up visit

  • Patient's hope for the future using the Herth Hope Index

    At enrollment and at 12-month follow-up visit

Study Arms (3)

Standard C02 Cryotherapy

ACTIVE COMPARATOR

Standard therapy using carbon dioxide for freezing of tissue

Device: Standard C02 Cryotherapy

Single Tip Thermoablation

EXPERIMENTAL

Thermoablator outfitted with a 19mm conical tip

Device: Single Tip Thermoablation

Multiple Tip Thermoablation

EXPERIMENTAL

Thermoablator outfitted with detachable probes

Device: Multiple Tip Thermoablation

Interventions

Standard C02 CryotherapyDEVICE

Standard therapy using carbon dioxide for freezing of tissue

Standard C02 Cryotherapy
Single Tip ThermoablationDEVICE

Thermoablator outfitted with a 19mm conical tip

Single Tip Thermoablation
Multiple Tip ThermoablationDEVICE

Thermoablator outfitted with detachable probes

Multiple Tip Thermoablation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Criteria for inclusion * Women aged 18 and older * Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified * Willing and able to provide informed consent * Willing and able to provide permanent or reliable address Criteria for exclusion * Pregnant or plans to become pregnant during study * History of total hysterectomy (verified by medical record or pelvic evaluation) * Previous surgery destructive to the cervix within the last 5 years * Patient not eligible for cryotherapy or thermoablation (lesion \>75% of cervix, lesion extends into canal or there is suspicion for invasive cancer) * Cervix shape disfigured or hard to reach

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Peking University Shenzhen Hospital

Shenzhen, China

Location

Hospital Nacional de la Mujer

San Salvador, El Salvador

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Miriam Cremer, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 12, 2018

Study Start

October 30, 2020

Primary Completion

March 30, 2025

Study Completion

July 1, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EL(1)CN(1)