Endometrial or Uterine PathologyNCT01789489
3D Ultrasound - Based Hysteroscopy Versus Virtual Hysteroscopy
A study testing Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography) in people with Endometrial or Uterine Pathology, run by Hopital Foch at 1 site in France.
Trial summary
To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial or Uterine Pathology
- What is being tested?
- Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic hysteroscopy prescribed either for a case of infertility or in case of doubt of endometrial / uterine pathology suspected by ultrasound or hysterography.
Who cannot join
- Current Pregnancy.
- Genital infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.
To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.
- Conditions
- Endometrial or Uterine Pathology
- Being tested
- Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)Device
| Study group | Role | What they receive |
|---|---|---|
| 3 dimensional sonohysterography | Active comparator | 3 dimensional sonohysterography Receives: Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography) |
| Standard hysteroscopy | Active comparator | Standard hysteroscopy Receives: Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial or Uterine PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie FAY, MD, Study chair, Hôpital FOCH 40, rue Worth 92150 Suresnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789489
- Sponsor's protocol ID
- 2010/12
- Status last verified
- Sep 2016
- First submitted
- 10 Jan 2013
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.
- ClinicalTrials.gov ID
- NCT01789489
- Acronym / sponsor ID
- 2010/12
- Conditions
- Endometrial or Uterine Pathology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 dimensional sonohysterography | Active comparator | Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)3 dimensional sonohysterography |
| Standard hysteroscopy | Active comparator | Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)Standard hysteroscopy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnostic hysteroscopy prescribed either for a case of infertility or in case of doubt of endometrial / uterine pathology suspected by ultrasound or hysterography.
Key exclusion criteria (2 listed)
- Current Pregnancy.
- Genital infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography) | Device | 3 dimensional sonohysterography, Standard hysteroscopy |
Primary outcome
Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography)
Time frame: 7 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie FAY, MD study chair
Hôpital FOCH 40, rue Worth 92150 Suresnes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography) in people with Endometrial or Uterine Pathology, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.