CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
CryoPen +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02814448
NCT02814448N/ACompleted
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CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings

The Cleveland Clinic·interventional·Posted Jun 27, 2016·Updated Nov 20, 2018

In Brief

A clinical study evaluating CryoPen, CO2 standard cryotherapy, and 1 other intervention for Cervical Intraepithelial Neoplasia. Completed, enrolled 130 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Intraepithelial Neoplasia
CountriesEl Salvador, Peru
CollaboratorsNational Cancer Institute (NCI), Basic Health International, Inc., CryoPen, Inc., University of Southern California, Albert Einstein College of Medicine

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 27, 2016
Enrollment StartFeb 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.0 years ago

Interventions

CryoPendevice

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

CO2 standard cryotherapydevice

Standard therapy using carbon dioxide for freezing of tissue

Thermocoagulatordevice

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