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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01789489
Other study ID # 2010/12
Secondary ID
Status Terminated
Phase N/A
First received January 10, 2013
Last updated September 22, 2016
Start date July 2010
Est. completion date January 2011

Study information

Verified date September 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France : Agence Française de Sécurité Sanitaire des Produits de Santé
Study type Interventional

Clinical Trial Summary

To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Diagnostic hysteroscopy prescribed either for a case of infertility or in case of doubt of endometrial / uterine pathology suspected by ultrasound or hysterography.

Exclusion Criteria:

- Current Pregnancy.

- Genital infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)


Locations

Country Name City State
France Hôpital FOCH Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography) 7 months No