Fallopian Tube Patency TestsNCT01053052
Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG
A study testing Sonography with FemVue, and HSG in people with Fallopian Tube Patency Tests, run by Femasys Inc..
Trial summary
Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fallopian Tube Patency Tests
- What is being tested?
- Sonography with FemVue, and HSG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2013
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:
- Been attempting conception for 6 months or
- A history of PID (including the conditions listed below) or
- Chlamydia
- Gonorrhea
- Endometriosis
Show all 11Show fewer
- A history of pelvic surgery or
- Advanced maternal age (≥ 35) And
- Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment
- Without current bi-lateral tubal sterilization
- Signed Informed Consent
Who cannot join
- Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)
- obstructing access to uterine cornu
- distorting fundus at the midline region
About this study
Official title: A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.
Read the detailed description
Study cancelled prior to recruitment.
- Conditions
- Fallopian Tube Patency Tests
- Being tested
- Sonography with FemVue, and HSG
- Keywords
- Patency Tests, Fallopian Tubes, Hysterosalpingography, Sonography, Medical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonography with FemVue, and HSGDevice
Sono HSG for FDA 510(k) cleared indication for use
| Study group | Role | What they receive |
|---|---|---|
| Sonography with FemVue vs. HSG | Experimental | FemVue sonography and HSG Receives: Device: Sonography with FemVue, and HSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of evaluations of fallopian tube patency and intrauterine pathology.
Measured: Day 1
Secondary outcomes (1)
subject discomfort assessment
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Study cancelled without recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube Patency TestsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Femasys Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053052
- Sponsor's protocol ID
- Femasys 300-001
- Status last verified
- May 2017
- First submitted
- 18 Jan 2010
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
- ClinicalTrials.gov ID
- NCT01053052
- Acronym / sponsor ID
- Femasys 300-001
- Conditions
- Fallopian Tube Patency Tests
- Keywords
- Patency Tests, Fallopian Tubes, Hysterosalpingography, Sonography, Medical
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled without recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Femasys Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Jan 2010 (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.
Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.
Detailed description
Study cancelled prior to recruitment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonography with FemVue vs. HSG | Experimental | Device: Sonography with FemVue, and HSGFemVue sonography and HSG |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:
- Been attempting conception for 6 months or
- A history of PID (including the conditions listed below) or
- A history of pelvic surgery or
- Advanced maternal age (≥ 35) And
Key exclusion criteria (3 listed)
- Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)
- obstructing access to uterine cornu
- distorting fundus at the midline region
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 |
|---|---|---|
| Sonography with FemVue, and HSGSono HSG for FDA 510(k) cleared indication for use | Device | Sonography with FemVue vs. HSG |
Primary outcome
Concordance of evaluations of fallopian tube patency and intrauterine pathology.
Time frame: Day 1
1 secondary outcome
subject discomfort assessment
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sonography with FemVue, and HSG in people with Fallopian Tube Patency Tests, run by Femasys Inc..
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 11 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Concordance of evaluations of fallopian tube patency and intrauterine pathology. (time frame: Day 1). 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 9 May 2017.