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An Innovative Treatment for Cervical Pre Cancer (CryoPen)

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ClinicalTrials.gov Identifier: NCT02814448
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Basic Health International
CryoPen, Inc.
University of Southern California
Albert Einstein College of Medicine
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Device: CryoPen Device: CO2 standard cryotherapy Device: Thermocoagulator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Measures :
  1. Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation [ Time Frame: 40 seconds to 13 minutes ]
    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).



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814448


Locations
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El Salvador
Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social
San Salvador, El Salvador
Peru
Instituto Nacional de Enfermedades Neoplásicas
Lima, Peru
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Basic Health International
CryoPen, Inc.
University of Southern California
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Miriam Cremer, MD The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02814448     History of Changes
Other Study ID Numbers: 15-296
UH2CA189883 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2016    Key Record Dates
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms