Tubal PatencyNCT01880073
FemVue and Tubal Patency
A study testing FemVue device in people with Tubal Patency, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
A thorough infertility evaluation commonly involves determining whether a woman's fallopian tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and fallopian tubes) and laparoscopic… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Tubal Patency
- What is being tested?
- FemVue device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 24 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.
Who cannot join
- Adnexal mass > 3.5cm or uterine size greater than 10 wks
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation
A thorough infertility evaluation commonly involves determining whether a woman's fallopian tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is visualized passing through the fallopian tubes).
The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by ultrasound. FemVue can be efficiently performed in a physician's office and is minimally invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast. It does, like the other two methods, carry a small risk of infection.
This study will involve using the FemVue device on patients under anesthesia in the operating room before they undergo scheduled laparoscopic chromopertubation, the gold standard for evaluating tubal patency. The two methods will be compared to determine the accuracy of the FemVue device.
Read the detailed description
Subjects who agree to participate will have their tubes evaluated by using the FemVue Saline-Air device and laparoscopic chromopertubation.
- Conditions
- Tubal Patency
- Being tested
- FemVue device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemVue deviceDevice
The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective.
| Study group | Role | What they receive |
|---|---|---|
| FemVue device | Experimental | FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective. Receives: Device: FemVue device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Had Concordant Findings
When the findings using the device was the same as the procedure. In other words, if the device found tubes to be patent (open) and it was confirmed with the laparoscopic chromopertubation, the findings are said to be concordant the same as if the device found tubes to be blocked and the laparoscopic chromopertubation found the same.
Measured: End of procedure, day 1.
Number of Subjects With Discordant Findings
When the findings between the FemVue and Laparoscopic Chromopertubation were discordant, efficacy of FemVue was determined with a third procedure, a Hysterosalpingogram. If the FemVue device found the tubes patent (open) and laparoscopic chromopertubation found them closed, the finding is considered discordant. To determine which finding is accurate a third procedure was performed which is a Hysteropsalpingogram, another way to determine tubal patency.
Measured: End of procedure, day 1.
Secondary outcomes (2)
The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device.
Measured: 10 mins after start of procedure
Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation.
Measured: End of procedure, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startMay 2012
- Primary completion24 May 2016
- Study completion24 May 2019
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tubal PatencyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Spandorfer, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880073
- Sponsor's protocol ID
- 1202012213
- Status last verified
- May 2020
- First submitted
- 21 May 2013
- Last updated
- 27 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation
- ClinicalTrials.gov ID
- NCT01880073
- Acronym / sponsor ID
- 1202012213
- Conditions
- Tubal Patency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- 24 May 2016 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A thorough infertility evaluation commonly involves determining whether a woman's fallopian tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is visualized passing through the fallopian tubes).
The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by ultrasound. FemVue can be efficiently performed in a physician's office and is minimally invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast. It does, like the other two methods, carry a small risk of infection.
This study will involve using the FemVue device on patients under anesthesia in the operating room before they undergo scheduled laparoscopic chromopertubation, the gold standard for evaluating tubal patency. The two methods will be compared to determine the accuracy of the FemVue device.
Detailed description
Subjects who agree to participate will have their tubes evaluated by using the FemVue Saline-Air device and laparoscopic chromopertubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FemVue device | Experimental | Device: FemVue deviceFemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.
Key exclusion criteria (1 listed)
- Adnexal mass > 3.5cm or uterine size greater than 10 wks
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 |
|---|---|---|
| FemVue deviceThe device will be used in conjunction with what is now considered the standard of care to determine if it's as effective. | Device | FemVue device |
Primary outcome
Number of Subjects Who Had Concordant Findings
Time frame: End of procedure, day 1.
When the findings using the device was the same as the procedure. In other words, if the device found tubes to be patent (open) and it was confirmed with the laparoscopic chromopertubation, the findings are said to be concordant the same as if the device found tubes to be blocked and the laparoscopic chromopertubation found the same.
Number of Subjects With Discordant Findings
Time frame: End of procedure, day 1.
When the findings between the FemVue and Laparoscopic Chromopertubation were discordant, efficacy of FemVue was determined with a third procedure, a Hysterosalpingogram. If the FemVue device found the tubes patent (open) and laparoscopic chromopertubation found them closed, the finding is considered discordant. To determine which finding is accurate a third procedure was performed which is a Hysteropsalpingogram, another way to determine tubal patency.
2 secondary outcomes
The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device.
Time frame: 10 mins after start of procedure
Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation.
Time frame: End of procedure, Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tubal Patency
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
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.
Steven Spandorfer, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemVue device in people with Tubal Patency, run by Weill Medical College of Cornell University at 1 site in United States.
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 1 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 27 May 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Had Concordant Findings (time frame: End of procedure, day 1.). The study lists 2 primary outcomes in all. 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 27 May 2020.