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

NCT02628873 | Terminated Results FDA Device

• 1 other identifier: Lindheim2015-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Keywords

HSG; HyCoSy; Contraception; Essure; Saline Infused sonography; SIS; Air bubbles

Outcome Measures

Primary Outcomes (1)

• Fallopian Tube Patency - HyCoSy vs HSG

  Observed flow of fluid/bubbles through fallopian tubes.

  At time of procedure

Secondary Outcomes (2)

• Pain Scores

  At time of procedures

• Physician Evaluation of Uterine Cavity

  At time of HyCoSy procedure

Study Arms (2)

Arm 1 (HyCoSy followed by HSG)

EXPERIMENTAL

HyCoSy procedure followed by HSG procedure

Device: HyCoSy

Arm 2 (HSG followed by HyCoSy)

EXPERIMENTAL

HSG procedure followed by HyCoSy procedure

Device: HyCoSy

Interventions

HyCoSy DEVICE

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

Also known as: Fem Vue, Saline Air Device, Saline infused sonogram

Arm 1 (HyCoSy followed by HSG); Arm 2 (HSG followed by HyCoSy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of unresolved dysfunctional uterine bleeding (DUB).
• History of a hysterectomy.
• Current urogenital disease.
• Abnormal pap smear.
• Positive urine pregnancy test.

Sponsors & Collaborators

• Wright State University: lead
• Bayer: collaborator

Study Sites (1)

Wright State Physicians

Dayton, Ohio, 45409, United States

Location

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  PMID: 32511207 RESULT

Results Point of Contact

• Title: Steven Lindheim
• Organization: Wright State University

doclalalindheim@gmail.com

858-740-1083

Study Officials

• Steven Lindheim, MD

  Wright State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor does not know which procedure was received first or second.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 22, 2024
• Results First Posted: August 31, 2020

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)