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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02814448 |
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Date of registration:
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13/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Innovative Treatment for Cervical Pre Cancer
CryoPen |
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Scientific title:
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CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02814448 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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El Salvador
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Peru
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Contacts
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Name:
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Miriam Cremer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Key inclusion & exclusion 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
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical Intraepithelial Neoplasia
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Intervention(s)
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Device: CO2 standard cryotherapy
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Device: CryoPen
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Device: Thermocoagulator
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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UH2CA189883
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15-296
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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