3D Ultrasound - Based Hysteroscopy Versus Virtual Hysteroscopy

NCT ID: NCT01789489

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial or Uterine Pathology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3 dimensional sonohysterography

3 dimensional sonohysterography

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Standard hysteroscopy

Standard hysteroscopy

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stéphanie FAY, MD

Role: STUDY_CHAIR

Hôpital FOCH 40, rue Worth 92150 Suresnes

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital FOCH

Suresnes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010/12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.