An Innovative Treatment for Cervical Pre Cancer (CryoPen)

CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings

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.

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Device: CryoPen; Device: CO2 standard cryotherapy; Device: Thermocoagulator

Detailed Description

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
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• El Salvador
  • San Salvador, El Salvador
    • Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social
• Peru
  • Lima, Peru
    • Instituto Nacional de Enfermedades Neoplasicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CO2 standard cryotherapy- double freeze; Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze	Device: CO2 standard cryotherapy; Standard therapy using carbon dioxide for freezing of tissue
Active Comparator: CO2 standard cryotherapy- single freeze; Single freeze treatment consists of one five-minute freeze	Device: CO2 standard cryotherapy; Standard therapy using carbon dioxide for freezing of tissue
Active Comparator: CryoPen- double freeze; Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze	Device: CryoPen; Provides a means of freezing tissue without the use of gases or liquids
Active Comparator: CryoPen- single freeze; Single freeze treatment consists of one five-minute freeze	Device: CryoPen; Provides a means of freezing tissue without the use of gases or liquids
Experimental: Thermocoagulator; Single heat application at 100 ºC for 40 seconds	Device: Thermocoagulator; The use of heat produced by high-frequency electric current to bring about local destruction of tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy	24-48 hours after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	40 seconds to 13 minutes

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: National Cancer Institute (NCI); Albert Einstein College of Medicine; University of Southern California; Basic Health International; CryoPen, Inc.
• Investigators: Principal Investigator: Miriam Cremer, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: 15-296; UH2CA189883 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No