NCT03084081

Brief Summary

The purpose of this academic-industrial partnership will compare the CryoPen® and thermoablator to traditional CO2-based cryotherapy for the treatment of cervical precancer in low and middle income countries (LMICs) and 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
1,132

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 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

March 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 6, 2025

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

7 years

First QC Date

March 14, 2017

Results QC Date

February 25, 2025

Last Update Submit

March 24, 2025

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Human Papilloma Virus (HPV)CryotherapyThermoablationThermocoagulationLow and Middle Income Countries (LMICs)

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants With Residual CIN2+

    Diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or higher with cervical cancer diagnosis

    12-months post treatment

Secondary Outcomes (1)

  • Self-reported Pain

    Pain during treatment

Study Arms (3)

CO2 standard therapy

ACTIVE COMPARATOR

Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze

Device: CO2 standard therapy

CryoPen

EXPERIMENTAL

Single freeze treatment consists of one five-minute freeze

Device: CryoPen

Thermocoagulator

EXPERIMENTAL

Thermoablation for 60-seconds at 100 degrees Celsius

Device: Thermocoagulator

Interventions

CO2 standard therapyDEVICE

Standard therapy using carbon dioxide for freezing of tissue

CO2 standard therapy
CryoPenDEVICE

Provides a means of freezing tissue without the use of gases or liquids

CryoPen
ThermocoagulatorDEVICE

Thermoablation

Thermocoagulator

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 (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 confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanxi Academy of Medical Sciences Shanxi Bethune Hospital

Taiyuan, China

Location

Hospital Universitario San Ignacio

Bogotá, Colombia

Location

Instituto Salvadoreno del Seguro Social (ISSS)

San Salvador, El Salvador

Location

Related Publications (1)

  • Soler M, Alfaro K, Masch RJ, Conzuelo Rodriguez G, Qu X, Wu S, Sun J, Hernandez Jovel DM, Bonilla J, Puentes LO, Murillo R, Alonzo TA, Felix JC, Castle P, Cremer M. Safety and Acceptability of Three Ablation Treatments for High-Grade Cervical Precancer: Early Data From a Randomized Noninferiority Clinical Trial. JCO Glob Oncol. 2022 Dec;8:e2200112. doi: 10.1200/GO.22.00112.

    PMID: 36525620DERIVED

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

Results Point of Contact

Title
Miriam Cremer, M.D.
Organization
Cleveland Clinic
cremerm@ccf.org
216-213-6460

Study Officials

  • Miriam Cremer, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

March 14, 2017

First Posted

March 20, 2017

Study Start

August 1, 2017

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

April 6, 2025

Results First Posted

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

IDP data will not be shared at the completion of the study.

Locations

EL(1)CN(1)CO(1)