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Slow recruitment
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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.
Subjects who agree to participate will have their tubes evaluated by using the FemVue Saline-Air device and laparoscopic chromopertubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FemVue device | Experimental | FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemVue device | Device | The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | End of procedure, day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device. | 10 mins after start of procedure | |
| Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation. | End of procedure, Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Spandorfer, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FemVue Device | FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective. FemVue device: The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FemVue Device | FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective. FemVue device: The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | End of procedure, day 1. |
|
Adverse event was monitored for a 2 week period post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FemVue Device | FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective. FemVue device: The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective. |
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Limitations on study participants have precluded us from achieving statistically reliable results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Spandorfer | Center for Reproductive Medicine | 646-962-3638 | sdspando@med.cornell.edu |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | End of procedure, day 1. |
|
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|
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| Secondary | The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device. | This information was not collected. | Posted | 10 mins after start of procedure |
|
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| Secondary | Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation. | This information was not collected. | Posted | End of procedure, Day 1 |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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