An Innovative Treatment for Cervical Pre Cancer

Cervical Intraepithelial Neoplasia Clinical Trial

— CryoPen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814448
• Other study ID #: 15-296
• Secondary ID: UH2CA189883
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

Device:
• CryoPen
Provides a means of freezing tissue without the use of gases or liquids
• CO2 standard cryotherapy
Standard therapy using carbon dioxide for freezing of tissue
• Thermocoagulator
The use of heat produced by high-frequency electric current to bring about local destruction of tissues

Locations

Country	Name	City	State
El Salvador	Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social	San Salvador
Peru	Instituto Nacional de Enfermedades Neoplásicas	Lima

Sponsors (6)

Lead Sponsor	Collaborator
The Cleveland Clinic	Albert Einstein College of Medicine, Inc., Basic Health International, CryoPen, Inc., National Cancer Institute (NCI), University of Southern California

Countries where clinical trial is conducted

El Salvador,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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