3D Ultrasound - Based Hysteroscopy Versus Virtual Hysteroscopy

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01789489
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometrial or Uterine Pathology	Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3 dimensional sonohysterography 3 dimensional sonohysterography	Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)
Active Comparator: Standard hysteroscopy Standard hysteroscopy	Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)

Outcome Measures

Primary Outcome Measures

1. Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography) [7 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital FOCH	Suresnes		France	92150

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Stéphanie FAY, MD, Hôpital FOCH 40, rue Worth 92150 Suresnes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01789489
• Other Study ID Numbers: 2010/12
• First Posted: Feb 12, 2013
• Last Update Posted: Sep 23, 2016
• Last Verified: Sep 1, 2016

Study Results

No Results Posted as of Sep 23, 2016