An Innovative Treatment for Cervical Pre Cancer

The Cleveland Clinic130 enrolled

Overview

The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.

The primary objectives of the study are to test the hypothesis that the CryoPen® and thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with traditional CO2-based cryotherapy and to test single versus double freeze applications. The secondary objectives of the study are to determine if the CryoPen® or thermocoagulator achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of cervical precancer, and to observe the relationship between depth of necrosis and variations in cervical anatomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Cervical Intraepithelial Neoplasia

Interventions

CryoPenDEVICE

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

CO2 standard cryotherapyDEVICE

Standard therapy using carbon dioxide for freezing of tissue

ThermocoagulatorDEVICE

The use of heat produced by high-frequency electric current to bring about local destruction of tissues

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Between 25 and 65 years old. * Scheduled for a hysterectomy for reasons other than cervical precancer or cancer * Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted * Histological evaluation of the cervix does not interfere with the woman's current diagnosis * Woman consents to participate after being informed about the study * Normal Pap Smear or HPV test in the past 3 years Exclusion Criteria: * Pregnancy * History of cervical surgery in past 5 years * Presence of cervical lesion pre-invasive or invasive on the cervix \* * Current Pelvic Inflammatory Disorder or severe acute cervicitis * Cervix shape disfigured or hard to reach

Locations (2)

Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social

San Salvador, El Salvador

Instituto Nacional de Enfermedades Neoplásicas

Lima, Peru

Outcomes

Primary Outcomes

Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy

Time frame: 24-48 hours after treatment

Secondary Outcomes

Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation

Scale Title: Pain scale during treatment Minimal value = 0 (no pain) Maximum value = 10 (most pain) This is a one item 11-point scale to measure self-reported pain during each of the treatments which lasted between 40 seconds (thermoablation) and 13 minutes (double freeze cryotherapy and double freeze CryoPen).

Time frame: 40 seconds to 13 minutes

Data from ClinicalTrials.gov

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