Clinical trial NCT02814448: An Innovative Treatment for Cervical Pre Cancer
Official title: CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Basic Health International
name: CryoPen, Inc.
name: University of Southern California
name: Albert Einstein College of Medicine
First posted: 2016-06-27
Enrollment: 130
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy
timeFrame: 24-48 hours after treatment
Secondary outcomes:
measure: Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation
timeFrame: 40 seconds to 13 minutes
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplásicas
Study officials:
affiliation: The Cleveland Clinic
name: Miriam Cremer, MD
role: PRINCIPAL_INVESTIGATOR
References: