Can SIS Using Air Bubbles Replace HSG for Fallopian Tubal Patency After Essure Placement

Contraception Clinical Trial

— HyCoSy  

Official title:

Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02628873
• Other study ID #: Lindheim2015-01
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: October 2018

Study information

• Verified date: August 2020
• Source: Wright State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates whether saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in patients who are undergoing an Essure confirmation test.

Description:

The gold standard for evaluating whether fallopian tubes are open versus closed is the X-ray hysterosalpingography (HSG). HSG is a radiologic procedure that is performed to verify that placement of the Essure tubal ligation inserts have successfully blocked the fallopian tubes. However, this procedure involved exposure to radiation. The saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) does not involve radiation and can be done in a physician's office. The HyCoSy air bubble device may be a lower cost, safer alternative procedure if it can be shown to provide similar results for tubal patency.

This study will compare the HyCoSy procedure results with the HSG procedure results in women who require the HSG procedure after receiving Essure tubal ligation inserts for their Essure confirmation test.

Women will be randomized to receive the HycoSy procedure first, followed by the HSG procedure or to the reverse order. Two independent readers will review the video results for both procedures to determine the degree of agreement on tubal patency.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documentation of normal Pap smear within 1 year prior to enrollment into study.

• Written informed consent given

• Need for evaluation of tubal status for post-Essure tubal occlusion

• Negative urine pregnancy test

Exclusion Criteria:

• History of unresolved dysfunctional uterine bleeding (DUB).

• History of a hysterectomy.

• Current urogenital disease.

• History of allergic response to IVP dye (exclusion for HSG).

• Abnormal pap smear.

• Positive urine pregnancy test.

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• HyCoSy
Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes

Locations

Country	Name	City	State
United States	Wright State Physicians	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Wright State University	Bayer

Country where clinical trial is conducted

United States, 

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fallopian Tube Patency - HyCoSy vs HSG	Observed flow of fluid/bubbles through fallopian tubes.	At time of procedure
Secondary	Pain Scores	Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces)	At time of procedures
Secondary	Physician Evaluation of Uterine Cavity	Observed image of uterus (normal or not normal). Assessor commented on uterine cavity to determine whether cavity was normal versus abnormal, e.g., bicornuate uterus or any notable uterine deformity. Data were coded as "normal' or "not normal".	At time of HyCoSy procedure