An Innovative Treatment for Cervical Pre Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CO2 standard cryotherapy- double freeze

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

Group Type ACTIVE_COMPARATOR

CO2 standard cryotherapy

Intervention Type DEVICE

Standard therapy using carbon dioxide for freezing of tissue

CO2 standard cryotherapy- single freeze

Single freeze treatment consists of one five-minute freeze

Group Type ACTIVE_COMPARATOR

CO2 standard cryotherapy

Intervention Type DEVICE

Standard therapy using carbon dioxide for freezing of tissue

CryoPen- double freeze

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

Group Type ACTIVE_COMPARATOR

CryoPen

Intervention Type DEVICE

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

CryoPen- single freeze

Single freeze treatment consists of one five-minute freeze

Group Type ACTIVE_COMPARATOR

CryoPen

Intervention Type DEVICE

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

Thermocoagulator

Single heat application at 100 ºC for 40 seconds

Group Type EXPERIMENTAL

Thermocoagulator

Intervention Type DEVICE

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

Interventions

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CryoPen

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

Intervention Type DEVICE

CO2 standard cryotherapy

Standard therapy using carbon dioxide for freezing of tissue

Intervention Type DEVICE

Thermocoagulator

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No