[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615277":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":57,"collaborators":60,"id":64,"slug":25,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Carevix","EXPERIMENTAL","Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.",[13],"Device: Carevix",{"label":15,"type":16,"description":17,"interventionNames":18},"Tenaculum","ACTIVE_COMPARATOR","Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.",[19],"Device: Tenaculum",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Vacuum cervical stabilization device",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard of care cervical stabilization device",[15],[30],{"name":31,"affiliation":32,"role":33},"Alissa M Conklin, MD","Indiana School of Medicine","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","317-944-8231","alconkli@iu.edu",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Kylie L Williams, MA","kylowill@iu.edu",[43],{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Indiana University Hospital","Indianapolis","Indiana","46202","United States",{"type":50,"coordinates":51},"Point",[52,53],-86.15804,39.76838,{"lat":53,"lon":52},[56],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":33,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Alissa M Conklin","Assistant Professor of Clinical Obstetrics and Gynecology",[61],{"name":62,"class":63},"Aspivix SA","INDUSTRY","100615277",false,"NCT07290517","Assessing Pain and Effectiveness of Carevix Device for IUD Insertions","The Carevix Device: Assessing Pain and Effectiveness of a Suction-based Cervical Stabilizer for IUD Insertions in the Clinic Setting: a Randomized, Controlled Trial (CARE)","CARE","Inclusion Criteria (to be assessed prior to procedure):\n\n* Age 18 years or older\n* Able to consent on their own\n* Scheduled and will undergo an IUD insertion within 90 days of consent\n* Planned use of cervical stabilization device for placement\n* Procedure being performed by a trained provider\n* Provider is willing to use Carevix™ for scheduled procedure\n\nExclusion Criteria (to be assessed by provider at time of procedure):\n\n* Vaginal bleeding of unknown origin\n* Cervix less than 26 mm in diameter\n* Nabothian cyst on anterior lip of cervix\n* Cervical myomas\n* Cervical abnormalities\u002Fshape\n* Pregnant\n* Participants who are not fluent in and\u002For do not fully understand, read, write, or speak the English language\n* Other inability to provide informed consent to participate\n* Initial attempt to place the IUD without any cervical stabilization","FEMALE","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between IUD insertions using a suction cervical stabilizer (new device, FDA approved, atraumatic) and single-tooth tenaculum (standard, traumatic). Our aims are to:\n\n* assess and compare patient-reported pain during IUD insertion between the Carevix device and tenaculum.\n* assess predictors of pain scores including between nulliparous and multiparous patients\n* assess provider-reported ease of use and satisfaction\n\nParticipants (including providers) will:\n\n* be randomized to receive one device to complete the IUD procedure\n* complete a survey following the procedure",[81,82,83],"IUD","Abnormal Uterine Bleeding","Pain, Cervical",[85,86,15,87],"IUD insertion","Cervical Stabilization","Pain","NOT_YET_RECRUITING","2026-01-12",{"date":91,"type":92},"2026-01-14","ACTUAL",{"date":94,"type":75},"2026-02",{"date":96,"type":75},"2027-02",{"name":5,"class":6},1]