Sponsor study identifier
observational
24
1 country
1
Study Start
September 1, 2016
Actual (reported)Primary Completion
July 31, 2017
Actual (reported)Study Completion
July 31, 2017
Actual (reported)The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2016
Actual (reported)July 31, 2017
Actual (reported)July 31, 2017
Actual (reported)August 26, 2019
Actual (reported)August 28, 2019
Actual (reported)December 10, 2019
Actual (reported)Intrauterine Fluid Volume Lost
After placement of the hysterosalpingogram catheter, investigators use an infusion pump to deliver normal saline under continuous pressure monitoring until reaching one of the following endpoints: delivery of the entire volume of 10mL (milliliter); a peak pressure of 450mmHg (millimeters of Mercury); or the participant requested the infusion to stop due to intolerable discomfort. After one minute, investigators withdraw the delivered fluid through the hysterosalpingogram catheter and record the volume instilled and recovered. They then repeat the procedure using contrast under fluoroscopy to confirm tubal patency or occlusion.
5 minutes
Tolerance of 10 ml Saline Infusion
5 minutes
Healthy women with history of Essure hysteroscopic permanent contraception. Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.
Healthy women with no history of permanent contraception. Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities.
An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Reproductive age (18-50 years) women in the Portland-metro area with either a history of Essure® hysteroscopic permanent contraception or healthy control participants without history of a permanent contraception procedure.
Oregon Health & Science University
Portland, Oregon, 97239, United States
Jeffrey Jensen, MD, MPH
Oregon Health and Science University
24 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2019
First Posted
August 28, 2019
Study Start
September 1, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 31, 2017
Actual (reported)Study Completion
July 31, 2017
Actual (reported)Last Updated
December 10, 2019
Results First Posted
December 10, 2019
Record last verified: 2019-12
Upon consenting and enrollment, subjects will be assigned a unique study identification code that will be used instead of their name, medical record number, or other personally identifying information. Data and/or specimens from this study will be kept in a repository and may be shared using the participant's unique study identification code with other investigators for future research.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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