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Lugol's Solution in Addition to Acetic Acid During Colposcopy

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ClinicalTrials.gov Identifier: NCT04415840
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Zydolab - Institute of Cytology and Immune Cytochemistry

Tracking Information
First Submitted Date June 1, 2020
First Posted Date June 4, 2020
Last Update Posted Date April 21, 2021
Actual Study Start Date May 31, 2020
Estimated Primary Completion Date March 25, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2020)
additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution [ Time Frame: 1 minute ]
We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 1, 2020)
  • Sensitivity [ Time Frame: 1 minute ]
    sensitivity of the examination (acetic acid + Lugol´s solution)
  • Specificity [ Time Frame: 1 minute ]
    Specificity of the examination (acetic acid + Lugol´s solution)
  • PPV [ Time Frame: 1 minute ]
    Positive predictive value of the examination (acetic acid + Lugol´s solution)
  • NPV [ Time Frame: 1 minute ]
    Negative predictive value of the examination (acetic acid + Lugol´s solution)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lugol's Solution in Addition to Acetic Acid During Colposcopy
Official Title Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia
Brief Summary To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Non-pregnant women referred for colposcopy due to cervical abnormalities
Condition Uterine Cervical Dysplasia
Intervention
  • Diagnostic Test: acetic acid test
    using acetic acid to unmask dysplastic lesions on the cervix uteri
  • Diagnostic Test: Lugol's solution test
    using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 1, 2020)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2023
Estimated Primary Completion Date March 25, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • women referred for colposcopy due to cervical abnormalities
  • written informed consent

Exclusion Criteria:

  • pregnant women
  • presence of a language barrier
  • history of conization or other treatments on the cervix uteri
  • iodine allergy
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Ziad Hilal, M.D. +0049 231 579349 z.hilal@zydolab.de
Contact: Clemens B. Tempfer, M.D., MBA +0049 2323 499 1801 clemens.tempfer@rub.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04415840
Other Study ID Numbers COLPO-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zydolab - Institute of Cytology and Immune Cytochemistry
Study Sponsor Zydolab - Institute of Cytology and Immune Cytochemistry
Collaborators Not Provided
Investigators
Principal Investigator: Ziad Hilal, M.D. Zydolab - Institute of Cytology and Immune Cytochemistry
PRS Account Zydolab - Institute of Cytology and Immune Cytochemistry
Verification Date April 2021