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

• Sponsor: Wright State University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02628873
• Collaborator: Bayer (Industry)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Device: HyCoSy	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes assessor does not know which procedure was received first or second.
• Primary Purpose: Diagnostic
• Official Title: Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 (HyCoSy followed by HSG) HyCoSy procedure followed by HSG procedure	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; Other Names: Fem Vue Saline Air Device Saline infused sonogram
Experimental: Arm 2 (HSG followed by HyCoSy) HSG procedure followed by HyCoSy procedure	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; Other Names: Fem Vue Saline Air Device Saline infused sonogram

Outcome Measures

Primary Outcome Measures

1. Fallopian Tube Patency - HyCoSy vs HSG [At time of procedure]

   Observed flow of fluid/bubbles through fallopian tubes.

Secondary Outcome Measures

1. Pain Scores [At time of procedures]

   Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces)

2. Physician Evaluation of Uterine Cavity [At time of HyCoSy procedure]

   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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wright State Physicians	Dayton	Ohio	United States	45409

Sponsors and Collaborators

• Wright State University
• Bayer

Investigators

• Principal Investigator: Steven Lindheim, MD, Wright State University

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Apr 19, 2016

More Information

Publications

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• Responsible Party: Steven Lindheim, MD, Professor, Wright State University
• ClinicalTrials.gov Identifier: NCT02628873
• Other Study ID Numbers: Lindheim2015-01
• First Posted: Dec 11, 2015
• Last Update Posted: Aug 31, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Steven Lindheim, MD, Professor, Wright State University: HSG; HyCoSy; Contraception; Essure; Saline Infused sonography; SIS; Air bubbles

Study Results

Participant Flow

Recruitment Details	Participants were recruited from existing practice and clinic patients who had the Essure device placed for contraception.

Arm/Group Title	Arm 1 (HyCoSy Followed by HSG)	Arm 2 (HSG Followed by HyCoSy)
Arm/Group Description	HyCoSy followed by HSG 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	HSG followed by HyCoSy 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
Period Title: First Test (1 Hour)
STARTED	14	7
COMPLETED	14	7
NOT COMPLETED	0	0
Period Title: First Test (1 Hour)
STARTED	14	7
COMPLETED	14	6
NOT COMPLETED	0	1
Period Title: First Test (1 Hour)
STARTED	14	6
COMPLETED	13	6
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Arm 1 (HyCoSy Followed by HSG)	Arm 2 (HSG Followed by HyCoSy)	Total
Arm/Group Description	HyCoSy procedure followed by HSG procedure 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	HSG procedure followed by HyCoSy procedure 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	Total of all reporting groups
Overall Participants	13	6	19
Overall # fallopian tubes	26	12	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.9 (6.7)	36.5 (6.7)	37.3 (6.5)
Sex: Female, Male (Count of Participants)
Female	13 100%	6 100%	19 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%	6 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Fallopian Tube Patency - HyCoSy vs HSG
Description	Observed flow of fluid/bubbles through fallopian tubes.
Time Frame	At time of procedure

Outcome Measure Data

Analysis Population Description

Analysis was per fallopian tube.

Arm/Group Title	Arm 1 (HyCoSy Followed by HSG)	Arm 2 (HSG Followed by HyCoSy)
Arm/Group Description	HyCoSy procedure followed by HSG procedure	HSG procedure followed by HyCoSy procedure
Measure Participants	13	6
Measure fallopian tubes observed to be closed	26	12
Number of tubes closed per first procedure	24	12
Number of tubes closed per second procedure	25	12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (HyCoSy Followed by HSG)
	Comments
	Type of Statistical Test	Equivalence
	Comments	Degree of agreement between the 2 Assessors
Statistical Test of Hypothesis	p-Value	< 0.01
	Comments
	Method	Kappa
	Comments
Method of Estimation	Estimation Parameter	Degree of agreement / Kappa
	Estimated Value	0.48
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Pain Scores
Description	Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces)
Time Frame	At time of procedures

Outcome Measure Data

Analysis Population Description

Change in patient reported pain scores (pre-procedure minus post-procedure pain scores)

Arm/Group Title	Arm 1 (HyCoSy Followed by HSG)	Arm 2 (HSG Followed by HyCoSy)
Arm/Group Description	HyCoSy procedure followed by HSG procedure	HSG procedure followed by HyCoSy procedure
Measure Participants	13	6
HSG post procedure pain score	1.4 (2.1)	1.8 (4.0)
HyCoSy post procedure pain score	2.4 (3.1)	2.3 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (HyCoSy Followed by HSG)
	Comments
	Type of Statistical Test	Superiority
	Comments	T-test to determine whether one method had greater reported pain
Statistical Test of Hypothesis	p-Value	< 0.30
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.925
	Confidence Interval	(2-Sided) 95%; -2.69 to 1.00
	Parameter Dispersion	Type: Standard Deviation; Value: 2.71
	Estimation Comments

3. Secondary Outcome

Title	Physician Evaluation of Uterine Cavity
Description	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".
Time Frame	At time of HyCoSy procedure

Outcome Measure Data

Analysis Population Description

Number of uteri assessed as 'normal'

Arm/Group Title	Arm 1 (HyCoSy Followed by HSG)	Arm 2 (HSG Followed by HyCoSy)
Arm/Group Description	HyCoSy procedure followed by HSG procedure	HSG procedure followed by HyCoSy procedure
Measure Participants	13	6
Count of Participants [Participants]	13 100%	6 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 (HyCoSy Followed by HSG)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.67
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test (pre-procedure versus post-procedure)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	- 0.431
	Confidence Interval	(2-Sided) 95%; - 2.40 to 1.56
	Parameter Dispersion	Type: Standard Deviation; Value: 2.76
	Estimation Comments

Adverse Events

Time Frame	1 week after procedures
Arm/Group Title	HyCoSy Followed by HSG		Hysterosalpingogram (HSG) Followed by HyCoSy
Arm/Group Description	HyCoSy followed by HSG 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 followed by: HSG performed to evaluate the patency (openness) of the fallopian tubes		Hysterosalpingogram (HSG) followed by HyCoSy HSG performed to evaluate the patency (openness) of the fallopian tubes followed by: 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
All Cause Mortality
	HyCoSy Followed by HSG		Hysterosalpingogram (HSG) Followed by HyCoSy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/6 (0%)
Serious Adverse Events
	HyCoSy Followed by HSG		Hysterosalpingogram (HSG) Followed by HyCoSy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	HyCoSy Followed by HSG		Hysterosalpingogram (HSG) Followed by HyCoSy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.