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Infectious Risk of Vaginal Ultrasound Examination: Evaluation and Modeling From Human Papillomavirus (HPV) (PREEV)

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ClinicalTrials.gov Identifier: NCT02659072
Recruitment Status : Unknown
Verified December 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination and probe disinfection. This will allow modeling the risk of HPV transmission, and could contribute establishing future guidelines for reducing the risk of transmission of microorganisms and the risk of infection through TVS.

Condition or disease
GYNAECOLOGICAL INFECTION

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Infectious Risk of Vaginal Ultrasound Examination: Evaluation and Modeling From Human Papillomavirus (HPV)
Study Start Date : January 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016



Primary Outcome Measures :
  1. Percentage and 95 % confidence interval of TVS procedures with bare probe positive for HPV [ Time Frame: 12 months ]
    Qualitative variable. Statistical unit: each procedure surveyed

  2. Percentage and 95 % confidence interval of TVS procedures with covered probe positive for HPV [ Time Frame: 12 months ]
    Qualitative variable. Statistical unit: each procedure surveyed


Secondary Outcome Measures :
  1. Percentage of procedures with keyboard positive for HPV [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit: each procedure surveyed. In addition, the number of disinfection items present will be added as a score.

  2. Percentage of procedures with visible rupture of probe cover [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit: each procedure surveyed. In addition, the number of disinfection items present will be added as a score.

  3. Percentage of procedures with visibly tainted probes [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit:

  4. Percentage of procedures with visible rupture of probe cover during previous procedure [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit:

  5. Percentage of procedures with visibly tainted probes during previous procedure [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit:

  6. Percentage of presence of each disinfection guideline item since last procedure and before the probe is tested for the presence of HPV [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit:

  7. Percentage of centers with a written protocol complying with disinfection guidelines [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit:

  8. percentage of centers with traceability of disinfection procedures. [ Time Frame: 12 months ]
    Qualitative variables will be analyzed as percentages of presence. Statistical unit:



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who will have an examination of endo-vaginal ultrasound
Criteria

Inclusion Criteria:

  • All examination of endo-vaginal ultrasound performed at participating center during a predetermined observation session,

Exclusion Criteria:

  • * Endo-Vaginal ultrasound with invasive procedure (with cutaneous or mucosal break)

    • Refusal of the patient that non-personal data are addressed in a study,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659072


Contacts
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Contact: Jean-Christophe LUCET, PHD 33 (0)1 40 25 61 94 jean-christophe.lucet@bch.aphp.fr
Contact: Sofia Zemouri, CRA Manager 33 (0) 01 47 60 67 25 sofia.zemouri@aphp.fr

Locations
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France
Hopital La Pitié Salpêtrire Recruiting
Paris, France, 75013
Contact: Marc Dommergues, Ph D    01 42 17 77 01    marc.dommergues@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Christophe LUCET, PHD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02659072    
Other Study ID Numbers: NI14013
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Communicable Diseases
Infection