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An Innovative Treatment for Cervical Pre Cancer

NCT02814448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2018-11-20

Study results available
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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.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

DEVICE

CryoPen

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

DEVICE

CO2 standard cryotherapy

Standard therapy using carbon dioxide for freezing of tissue

DEVICE

Thermocoagulator

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Basic Health International

    collaborator OTHER

  • CryoPen, Inc.

    collaborator OTHER

  • University of Southern California

    collaborator OTHER

  • Albert Einstein College of Medicine

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Miriam Cremer, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • El Salvador
  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02814448 on ClinicalTrials.gov