Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 2:29 PM
Study NCT ID:
NCT04071392
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'whru@ohsu.edu', 'phone': '503-494-3666', 'title': 'OB/Gyn Regulatory Specialist', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Per protocol, Adverse Event data were not collected for this study.', 'description': 'Per protocol, Adverse Event data were not collected for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Post-Essure Group', 'description': 'Healthy women with history of Essure hysteroscopic permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Healthy women with no history of permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intrauterine Fluid Volume Lost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Essure Group', 'description': 'Healthy women with history of Essure hysteroscopic permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Healthy women with no history of permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.8'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '8.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 minutes', 'description': '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.\n\nAfter 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.', 'unitOfMeasure': 'ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tolerance of 10 ml Saline Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Essure Group', 'description': 'Healthy women with history of Essure hysteroscopic permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Healthy women with no history of permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}], 'classes': [{'categories': [{'title': 'Tolerated 10 ml saline', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Did not tolerate 10 ml saline', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 minutes', 'description': '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.\n\nThe proportion of participants who tolerated the full 10 ml of infused saline was compared between groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Post-Essure Group', 'description': 'Healthy women with history of Essure hysteroscopic permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Healthy women with no history of permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Post-Essure Group', 'description': 'Healthy women with history of Essure hysteroscopic permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Healthy women with no history of permanent contraception.\n\nEligible 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.\n\nHysterosalpingogram (HSG): 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '38.4', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '38.9', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-17', 'size': 406275, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-12T15:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-08-26', 'resultsFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-09', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intrauterine Fluid Volume Lost', 'timeFrame': '5 minutes', 'description': '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.\n\nAfter 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.'}], 'secondaryOutcomes': [{'measure': 'Tolerance of 10 ml Saline Infusion', 'timeFrame': '5 minutes', 'description': '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.\n\nThe proportion of participants who tolerated the full 10 ml of infused saline was compared between groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hysterosalpingogram (HSG)', 'permanent contraception', 'tubal occlusion', 'tubal patency'], 'conditions': ['Sterilization, Female', 'Fallopian Tube Occlusion']}, 'descriptionModule': {'briefSummary': 'The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception.', 'detailedDescription': 'The hystero-(uterus)salpingo-(fallopian tube)graphy (HSG) study is a standard radiological imaging study used to evaluate the internal female reproductive parts, the uterus and fallopian tubes. The tubes are a passage that allows fluid and cells to flow between the body cavity and the uterus. Normally, both tubes are open to this flow, a condition called "tubal patency". If one or both tubes is blocked preventing flow of fluid, this is called "tubal occlusion". If there is tubal patency, as the pressure increases in the uterine cavity, fluid will move through the tubes into the body cavity. If the tubes are occluded, pressure will increase in the uterus but the fluid will not move into the tubes.\n\nThe long-term goal is to develop an alternative test to confirm both fallopian tubes are blocked after a non-surgical permanent contraception (sterilization) procedure. Currently tubal patency is determined by HSG.\n\nIn this study, the investigators evaluate the potential for alternative diagnostic office tests. The study will evaluate whether uterine pressure measurements can predict tubal patency, or whether the change in volume following intrauterine administration of a fixed volume of saline followed by aspiration predicts tubal patency.\n\nPrior to the instillation of contrast solution, investigators will administer a fixed volume of saline at a constant rate until we reach a volume of 10 ml, or the limit of tolerability for the patient. After a wait of 1 min, they will attempt to aspirate the saline, and measure the difference between fluid in and fluid out. The study will also measure intrauterine pressure during the procedure.\n\nFollowing the saline test, an HSG is done to assess tubal patency.\n\nThis study will evaluate healthy parous women in the late follicular phase and women with a history of Essure permanent contraception.\n\nThe investigators hypothesize that women with a history of Essure will have higher uterine pressure, higher volume of fluid recovered, and bilateral tubal occlusion by HSG.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Literate in English\n2. Ages 18-50 years\n3. No history of infertility, and current regular menstrual cycles occurring every 24-37 days\n4. At least one full-term vaginal delivery\n5. Not be at risk for pregnancy\n6. Be willing to undergo a one month washout period if using the pill, patch or ring, or a three month wash out period if using Depo-Medroxyprogesterone acetate (DMPA)\n7. Willing to undergo intrauterine saline infusion followed by a single HSG procedure\n8. Able to understand and sign approved study informed consent form\n9. Willing to complete a pre-procedure questionnaire\n\nExclusion Criteria:\n\n1. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test\n2. Currently using an intrauterine device (IUD) or contraceptive implant\n3. Hypersensitive to radio-opaque contrast\n4. History of cesarean section\n5. History of tubal ligation by a method other than Essure® or Adiana\n6. History recognized as clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection'}, 'identificationModule': {'nctId': 'NCT04071392', 'briefTitle': 'Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Pressure Dynamics in the Non-gravid Uterus: Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion After Nonsurgical Permanent Contraception', 'orgStudyIdInfo': {'id': 'OHSU IRB 11443'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-Essure Group', 'description': 'Healthy women with history of Essure hysteroscopic permanent contraception.\n\nEligible 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.', 'interventionNames': ['Procedure: Hysterosalpingogram (HSG)']}, {'label': 'Control Group', 'description': 'Healthy women with no history of permanent contraception.\n\nEligible 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.', 'interventionNames': ['Procedure: Hysterosalpingogram (HSG)']}], 'interventions': [{'name': 'Hysterosalpingogram (HSG)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Control Group', 'Post-Essure Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Jeffrey Jensen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '12 months after publication', 'ipdSharing': 'YES', 'description': "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.\n\nData 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.", 'accessCriteria': 'Must have Oregon Health \\& Science University (OHSU) Institutional Review Board (IRB) approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Womens Imaging & Intervention', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeffrey Jensen', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}