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Completed

NCT Number: NCT02814448

An Innovative Treatment for Cervical Pre Cancer

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social, San Salvador, El Salvador

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CryoPen

Device

Provides a means of freezing tissue without the use of gases or liquids

CO2 standard cryotherapy

Device

Standard therapy using carbon dioxide for freezing of tissue

Thermocoagulator

Device

The use of heat produced by high-frequency electric current to bring about local destruction of tissues

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Albert Einstein College of Medicine
  • Basic Health International, Inc.
  • CryoPen, Inc.
  • National Cancer Institute (NCI)
  • University of Southern California

Registry information

Official study title

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

Acronym: CryoPen

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 27, 2016
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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