Tubal Patency
Conditions
Brief 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 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.
Interventions
DEVICEFemVue device
The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.
Exclusion criteria
* Adnexal mass \> 3.5cm or uterine size greater than 10 wks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Had Concordant Findings | 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 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation. | End of procedure, Day 1 |
| The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device. | 10 mins after start of procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | FemVue Device | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 24 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 24 Participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
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.
Time frame: End of procedure, day 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FemVue Device | Number of Subjects Who Had Concordant Findings | 21 Participants |
95% CI: [0.74, 1]
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.
Time frame: End of procedure, day 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FemVue Device | Number of Subjects With Discordant Findings | 3 Participants |
95% CI: [0, 0.26]
Secondary
The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device.
Time frame: 10 mins after start of procedure
Population: This information was not collected.
Secondary
Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation.
Time frame: End of procedure, Day 1
Population: This information was not collected.