Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT01327105
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2011-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Essure Transvaginal Ultrasound (TVU) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 547}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': 'Annually beginning at one year', 'description': 'Rate of pregnancy at 1 and 10 years among subjects relying on Essure micro-inserts for birth control on the basis of the TVU/HSG algorithm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Contraceptive Usage']}, 'referencesModule': {'references': [{'pmid': '28669895', 'type': 'DERIVED', 'citation': 'Vleugels M, Cheng RF, Goldstein J, Bangerter K, Connor V. Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1128-1135. doi: 10.1016/j.jmig.2017.06.021. Epub 2017 Jun 29.'}]}, 'descriptionModule': {'briefSummary': "The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is called a hysterosalpingogram and evaluates the location of the inserts and whether the fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to evaluate the location of the inserts.\n\nThe purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.", 'detailedDescription': 'This study has previously been posted by Conceptus, Inc. (USA).\n\nAfter acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who are 21 to 44 years of age\n* Women who are between 90-300 pounds (40-136 kilograms)\n* Women who are scheduled to undergo an Essure micro-insert placement procedure for permanent birth control\n* Women who are willing to accept the risk of pregnancy occurring while relying on the Essure device for prevention of pregnancy\n* Women who are believed to have two viable fallopian tubes\n* Women who are able and willing to provide written informed consent\n* Women who have the mental capacity to understand the Informed Consent, comply with the protocol requirements, and provide reliable feedback regarding device wearing\n* Women who can be available for all study visits\n* Women who are willing to allow data to be shared with the sponsor and with regulatory bodies\n* Women who are not contraindicated for the Essure procedure according to the Essure Instructions for Use (IFU)\n\nExclusion Criteria:\n\n* Women who have known proximal tubal occlusion in either fallopian tube\n* Women who have had a fallopian tube sterilization procedure\n* Women who have a unicornuate uterus\n* Women who have known endometrial or myometrial pathology that is likely to prevent access to the fallopian tube ostia\n* Women who are scheduled to undergo any other intrauterine procedures at the time of Essure placement\n* Women who are pregnant or suspected of being pregnant\n* Women who have had a delivery or termination of pregnancy within the last six weeks\n* Women who have an active or recent upper or lower pelvic infection\n* Women who are contraindicated for Essure micro-insert placement according to the Essure Instructions for Use (IFU)\n* Women who have a known intolerance to transvaginal imaging'}, 'identificationModule': {'nctId': 'NCT01327105', 'briefTitle': 'Essure Transvaginal Ultrasound (TVU) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness', 'orgStudyIdInfo': {'id': '16974'}, 'secondaryIdInfos': [{'id': 'ESS-TVU', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TVU', 'interventionNames': ['Device: TVU']}], 'interventions': [{'name': 'TVU', 'type': 'DEVICE', 'description': 'Use of transvaginal ultrasound to determine location of micro-insert', 'armGroupLabels': ['TVU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '80005', 'city': 'Arvada', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.80276, 'lon': -105.08748}}, {'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43231', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'S4P 0W5', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': '1061 AE', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2134 TM', 'city': 'Hoofddorp', 'country': 'Netherlands', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '4002 WP', 'city': 'Tiel', 'country': 'Netherlands', 'geoPoint': {'lat': 51.88667, 'lon': 5.42917}}, {'zip': '5504 DB', 'city': 'Veldhoven', 'country': 'Netherlands', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'zip': '8025 AB', 'city': 'Zwolle', 'country': 'Netherlands', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}