[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615277":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":90,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Indiana University Hospital","Indianapolis","Indiana","46202","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-86.15804,39.76838,{"lat":54,"lon":53},[57],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Alissa M Conklin","Assistant Professor of Clinical Obstetrics and Gynecology",[62],{"name":63,"class":64},"Aspivix SA","INDUSTRY","100615277","assessing-pain-and-effectiveness-of-carevix-device-for-iud-insertions-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":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[80],"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",[83,84,85],"IUD","Abnormal Uterine Bleeding","Pain, Cervical",[87,88,15,89],"IUD insertion","Cervical Stabilization","Pain","NOT_YET_RECRUITING","2026-01-12",{"date":93,"type":94},"2026-01-14","ACTUAL",{"date":96,"type":77},"2026-02",{"date":98,"type":77},"2027-02",{"name":5,"class":6},1]