search
Back to results

An Innovative Treatment for Cervical Pre Cancer (CryoPen)

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CryoPen
CO2 standard cryotherapy
Thermocoagulator
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social
  • Instituto Nacional de Enfermedades Neoplásicas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

CO2 standard cryotherapy- double freeze

CO2 standard cryotherapy- single freeze

CryoPen- double freeze

CryoPen- single freeze

Thermocoagulator

Arm Description

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

Single freeze treatment consists of one five-minute freeze

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

Single freeze treatment consists of one five-minute freeze

Single heat application at 100 ºC for 40 seconds

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
June 13, 2016
Last Updated
October 22, 2018
Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI), Basic Health International, CryoPen, Inc., University of Southern California, Albert Einstein College of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02814448
Brief Title
An Innovative Treatment for Cervical Pre Cancer
Acronym
CryoPen
Official Title
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI), Basic Health International, CryoPen, Inc., University of Southern California, Albert Einstein College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO2 standard cryotherapy- double freeze
Arm Type
Active Comparator
Arm Description
Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze
Arm Title
CO2 standard cryotherapy- single freeze
Arm Type
Active Comparator
Arm Description
Single freeze treatment consists of one five-minute freeze
Arm Title
CryoPen- double freeze
Arm Type
Active Comparator
Arm Description
Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze
Arm Title
CryoPen- single freeze
Arm Type
Active Comparator
Arm Description
Single freeze treatment consists of one five-minute freeze
Arm Title
Thermocoagulator
Arm Type
Experimental
Arm Description
Single heat application at 100 ºC for 40 seconds
Intervention Type
Device
Intervention Name(s)
CryoPen
Intervention Description
Provides a means of freezing tissue without the use of gases or liquids
Intervention Type
Device
Intervention Name(s)
CO2 standard cryotherapy
Intervention Description
Standard therapy using carbon dioxide for freezing of tissue
Intervention Type
Device
Intervention Name(s)
Thermocoagulator
Intervention Description
The use of heat produced by high-frequency electric current to bring about local destruction of tissues
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Cremer, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social
City
San Salvador
Country
El Salvador
Facility Name
Instituto Nacional de Enfermedades Neoplásicas
City
Lima
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Innovative Treatment for Cervical Pre Cancer

We'll reach out to this number within 24 hrs