Trial Outcomes & Findings for Can SIS Using Air Bubbles Replace HSG for Fallopian Tubal Patency After Essure Placement (NCT NCT02628873)

NCT ID: NCT02628873

Last Updated: 2024-10-22

Results Overview

Observed flow of fluid/bubbles through fallopian tubes.

Recruitment status

TERMINATED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

At time of procedure

Results posted on

2024-10-22

Participant Flow

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

Participant milestones

Participant milestones
Measure	Arm 1 (HyCoSy Followed by HSG) 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	Arm 2 (HSG Followed by HyCoSy) 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
First Test (1 Hour) STARTED	14	7
First Test (1 Hour) COMPLETED	14	7
First Test (1 Hour) NOT COMPLETED	0	0
Break (1 Hour) STARTED	14	7
Break (1 Hour) COMPLETED	14	6
Break (1 Hour) NOT COMPLETED	0	1
Second Test (1 Hour) STARTED	14	6
Second Test (1 Hour) COMPLETED	13	6
Second Test (1 Hour) NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 (HyCoSy Followed by HSG) 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	Arm 2 (HSG Followed by HyCoSy) 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
Break (1 Hour) Withdrawal by Subject	0	1
Second Test (1 Hour) Physician Decision	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (HyCoSy Followed by HSG) n=26 # fallopian tubes 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	Arm 2 (HSG Followed by HyCoSy) n=12 # 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 n=38 # fallopian tubes Total of all reporting groups
Age, Continuous	37.9 years STANDARD_DEVIATION 6.7 • n=13 Participants	36.5 years STANDARD_DEVIATION 6.7 • n=6 Participants	37.3 years STANDARD_DEVIATION 6.5 • n=19 Participants
Sex: Female, Male Female	13 Participants n=13 Participants	6 Participants n=6 Participants	19 Participants n=19 Participants
Sex: Female, Male Male	0 Participants n=13 Participants	0 Participants n=6 Participants	0 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 participants n=13 Participants	6 participants n=6 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: At time of procedure

Population: Analysis was per fallopian tube.

Observed flow of fluid/bubbles through fallopian tubes.

Outcome measures

Outcome measures
Measure	Arm 1 (HyCoSy Followed by HSG) n=26 fallopian tubes observed to be closed HyCoSy procedure followed by HSG procedure	Arm 2 (HSG Followed by HyCoSy) n=12 fallopian tubes observed to be closed HSG procedure followed by HyCoSy procedure
Fallopian Tube Patency - HyCoSy vs HSG Number of tubes closed per first procedure	24 fallopian tubes observed to be closed	12 fallopian tubes observed to be closed
Fallopian Tube Patency - HyCoSy vs HSG Number of tubes closed per second procedure	25 fallopian tubes observed to be closed	12 fallopian tubes observed to be closed

SECONDARY outcome

Timeframe: At time of procedures

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

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

Outcome measures

Outcome measures
Measure	Arm 1 (HyCoSy Followed by HSG) n=13 Participants HyCoSy procedure followed by HSG procedure	Arm 2 (HSG Followed by HyCoSy) n=6 Participants HSG procedure followed by HyCoSy procedure
Pain Scores HSG post procedure pain score	1.4 units on a scale Standard Deviation 2.1	1.8 units on a scale Standard Deviation 4.0
Pain Scores HyCoSy post procedure pain score	2.4 units on a scale Standard Deviation 3.1	2.3 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: At time of HyCoSy procedure

Population: Number of uteri assessed as 'normal'

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".

Outcome measures

Outcome measures
Measure	Arm 1 (HyCoSy Followed by HSG) n=13 Participants HyCoSy procedure followed by HSG procedure	Arm 2 (HSG Followed by HyCoSy) n=6 Participants HSG procedure followed by HyCoSy procedure
Physician Evaluation of Uterine Cavity	13 Participants	6 Participants

Adverse Events

HyCoSy Followed by HSG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hysterosalpingogram (HSG) Followed by HyCoSy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Lindheim

Wright State University

Phone: 858-740-1083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place