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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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19 February 2024 |
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Main ID: |
NCT03084081 |
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Date of registration:
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14/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Innovative Treatment for Cervical Precancer (UH3)
UH3 |
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Scientific title:
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A Randomized Controlled Trial Comparing Cure Rates of Cervical Intraepithelial Neoplasia Grade 2 and Higher (CIN2+) Treated With CO2-based Cryotherapy, CropPen, and Thermoablation (UH3) |
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Date of first enrolment:
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August 1, 2017 |
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Target sample size:
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1130 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03084081 |
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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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China
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Colombia
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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:
- Women aged 18 and older
- Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified
- Willing and able to provide informed consent
- Willing and able to provide permanent or reliable address
Exclusion Criteria:
- Pregnant or plans to become pregnant during study
- History of total hysterectomy (verified by medical record or pelvic evaluation)
- Previous surgery destructive to the cervix within the last 5 years
- Patient not eligible for cryotherapy (lesion >75% of cervix, lesion extends into canal
or there is suspicion for invasive cancer)
- Cervix shape disfigured or hard to reach
Age minimum:
18 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: Thermocoagulator
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Device: CryoPen
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Device: CO2 standard therapy
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Primary Outcome(s)
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Residual CIN2+
[Time Frame: 12-months post treatment]
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Secondary Outcome(s)
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Pain
[Time Frame: Immediately after treatment]
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Secondary ID(s)
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UH3CA189883
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17-294
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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