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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03493724
Other study ID # 2017-A02607-46
Secondary ID
Status Recruiting
Phase
First received March 9, 2018
Last updated April 9, 2018
Start date February 13, 2018
Est. completion date September 1, 2018

Study information

Verified date February 2018
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To study the diagnostic performance of the images on the smartphone compare the result of the clinical examination, all the dermatoses combined and by family of pathology (inflammatory, wound, oncology, infectious, allergology), during urgent request requests in dermatology


Description:

The study is conducted in the dermatology department, for a maximum duration of 6 months. We include patients who require dermatological advice and for whom their doctor sends us photographs.

Doctors contact us by telephone, describe the symptoms and send photographs according to the secure procedure.

Patients are admitted for consultation and the diagnosis by photography is compared with the clinical diagnosis


Recruitment information / eligibility

Status Recruiting
Enrollment 205
Est. completion date September 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For which our fellow doctors ask a dermatological opinion for diagnostic purposes, after clinical examination of the patient, in an emergency

- After obtaining the oral consent by the requesting doctor then informing and signing a non-opposition form during the consultation at the University Hospital of Nancy

- Affiliation to a social protection

- Doctors must have signed and sent back an ethical charter, where they undertake to send the image via MSsante, then to erase the image of the smartphone

Exclusion Criteria:

- Patients under the protection of justice, tutorship or curatorship

- Doctors : lack of smartphone powerful enough to offer a quality image

Study Design


Related Conditions & MeSH terms


Intervention

Other:
telemedecine
to evaluate the diagnostic performance of the photographs made by Smartphone, during requests for emergency dermatological advice

Locations

Country Name City State
France CHRU Nancy, hopitaux de Brabois Nancy Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity, specificity, positive and negative predictive values globally evaluation of the diagnostic performance of the test through study completion, an average 6 months
Primary sensitivity, specificity, positive and negative predictive values stratified stratified on the families of pathologies : infectious pathology, inflammatory dermatosis, allergology, wound, oncology through study completion, an average 6 months
Secondary Calculation of Cohen's kappa concordance between dermatologists assessment of interobserver diagnostic agreement through study completion, an average 6 months
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