Clinical Trials Directory

Trials / Completed

CompletedNCT04908839

Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)

Status
Completed
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Inclusion (J0): * Audiometry (as part of the treatment, only for cases) * Clinical evaluation (within the framework of care, only for cases) * Passage of the French version of the SPOT-25 questionnaire Visit 1 (D0 + 3 ± 1 week): only for cases Second examination of the French version of the SPOT-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame. Visit 2 (3-6 months postoperatively): only for operated patients Third examination of the French version of the SPOT-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

Detailed description

Inclusion (J0): * Audiometry (as part of the treatment, only for cases) * Clinical evaluation (within the framework of care, only for cases) * Passage of the French version of the SPOT-25 questionnaire Visit 1 (D0 + 3 ± 1 week): only for cases Second examination of the French version of the SPOT-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame. Visit 2 (3-6 months postoperatively): only for operated patients Third examination of the French version of the SPOT-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

Conditions

Interventions

TypeNameDescription
OTHERspot-25 questionnairespot-25 questionnaire

Timeline

Start date
2021-09-09
Primary completion
2022-04-06
Completion
2022-04-06
First posted
2021-06-01
Last updated
2023-02-14

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04908839. Inclusion in this directory is not an endorsement.