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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02814448
Other study ID # 15-296
Secondary ID UH2CA189883
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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