Status:
COMPLETED
Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
25-64 years
Phase:
NA
Brief Summary
To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar side effects an...
Detailed Description
Healthy women aged 25 to 64 yrs with histology confirmed ectocervical CIN lesions confined to ectocervix without extension to endocervix or vagina will be randomized to single- or double-freeze cryoth...
Eligibility Criteria
Inclusion
- Inclusion Criteria Apparently healthy women aged 25 to 64 yrs with following criteria will be eligible to participate in the study.
- Histological confirmation of ASCUS -H, CIN I, CIN II and CIN III lesions.
- The lesion confined to ecto cervix only.
- No obvious cervical and vaginal infection.
- Women in proliferative phase of menstrual cycle or post menopausal cases.
- Negative endo cervical curettage.
- Exclusion criteria Women less than 25 and more than 64 years will not be enrolled.
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT01145781
Start Date
January 1 2010
End Date
January 1 2015
Last Update
May 1 2018
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India