NCT01145781

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 and complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

5 years

First QC Date

June 16, 2010

Last Update Submit

April 27, 2018

Conditions

Cervical Intraepithelial Neoplasia

Keywords

ectocervical CIN lesions

Outcome Measures

Primary Outcomes (1)

  • The primary end point is the cure rate at the end of one year

    The primary end point is the cure rate at the end of one year by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze.

    1 year

Secondary Outcomes (1)

  • The secondary end points are the rates and the types of side effects and complications

    1 year

Study Arms (2)

Single-freeze cryotherapy

ACTIVE COMPARATOR

Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw.

Procedure: Cryotherapy

Double-freeze cryotherapy

ACTIVE COMPARATOR

Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.

Procedure: Cryotherapy

Interventions

CryotherapyPROCEDURE

Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.

Double-freeze cryotherapySingle-freeze cryotherapy

Eligibility Criteria

Age25 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, India

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gauravi A MIshra, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Sharmila A Pimple, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor Department of Preventive Oncology

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

IN(1)