[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ethicon, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,69,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100426144","ethicon-pelvic-mesh-post-market-clinical-follow-up-registry-100426144",false,"NCT04829175","Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry","A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse","Inclusion Criteria:\n\nPatients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:\n\nSUI\n\n1. Stress urinary incontinence symptoms\n2. Urodynamic stress incontinence confirmed with urodynamic testing\n3. Female patient ≥ 21 years of age\n4. Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling\n5. Planned surgery for primary SUI\n6. Patient able and willing to participate in follow-up\n7. Patient or authorized representative has signed the approved Informed consent POP\n\n1\\. Uterine or vaginal vault prolapse symptoms 2. Urodynamic testing (optional) 3. Female patient ≥ 21 years of age 4. Desired surgical correction of POP using synthetic mesh 5. Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent\n\nExclusion Criteria\n\nPatients meeting any of the following criteria will be considered not eligible for enrollment in this registry:\n\n1. Physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires\n2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products\n3. History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)\n4. Pregnancy or plans for future pregnancy\n5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice\n6. Current genitourinary fistula or urethral diverticulum\n7. Reversible cause of incontinence (i.e. drug effect) for SUI only\n8. Severe vaginal atrophy\n9. History of pelvic irradiation therapy\n10. Contraindication to surgery","FEMALE","21 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.",[24,25],"Stress Urinary Incontinence","Pelvic Organ Prolapse",[24,25,27,28],"SUI","POP","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-26","ACTUAL",{"date":35,"type":33},"2022-04-11",{"date":37,"type":20},"2038-03-31",{"name":39,"class":40},"Ethicon, Inc.","INDUSTRY",10,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100567177","a-study-of-ethizia-versus-surgicel-original-in-controlling-soft-tissue-bleeding-during-open-surgery-100567177","NCT06664788","A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery","A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thoracic (Non-cardiac) and Extremity Surgery","Inclusion Criteria:\n\nPre-operative\n\n* Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure\n* Participant is willing and able to give written informed consent for the clinical investigation participation\n\nIntra-operative\n\n* Participant in whom the Investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical\n* Target Bleeding Site is identified to originate from soft tissue, defined as organ bed, loose areolar tissue, fat, lymphatic tissue\u002Flymph node beds, and muscle\n* The choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis\n* Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities)\n\nExclusion Criteria:\n\nPre-operative\n\n* Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application\n* Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid\n* Participant has an active or suspected infection at the bleeding site\n* Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period\n\nIntra-operative\n\n* Target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine\n* Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency","ALL","22 Years",{"count":52,"type":20},108,"INTERVENTIONAL",[55],"NA","The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.",[58,59],"Hemostasis","Hemostatic Techniques","2026-06-04",{"date":62,"type":33},"2026-06-05",{"date":64,"type":33},"2025-04-16",{"date":66,"type":20},"2026-07-30",{"name":39,"class":40},7,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100426135","gynemesh-ps-mesh-post-marketing-clinical-follow-up-study-100426135","NCT04829058","GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study","A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh","Inclusion Criteria:\n\nSubjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:\n\n1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse\n2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.\n3. Able and willing to participate in follow-up\n4. Subject or authorized representative has signed the approved informed consent\n\nExclusion Criteria\n\nSubjects meeting any of the following criteria will be considered not eligible for enrollment in this study:\n\n1. Subjects \\\u003C 21 years of age at the time of informed consent\n2. Subjects who had transvaginal approach for surgery\n3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)",{"count":77,"type":20},100,"The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.",[25],[81,28],"GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh",{"date":62,"type":33},{"date":84,"type":33},"2021-11-24",{"date":86,"type":20},"2032-03-31",{"name":39,"class":40},3,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":5},"100426158","post-market-clinical-follow-up-study-on-tvt-abbrevo-continence-system-100426158","NCT04829357","Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System","A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence","Inclusion Criteria:\n\nSubjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:\n\n1. Stress urinary incontinence symptoms\n2. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.\n3. Female subjects ≥ 21 years of age requiring treatment of SUI\n4. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings\n5. Planned surgery for primary stress incontinence without concomitant prolapse surgery\n6. Patient able and willing to participate in follow-up\n7. Subject or authorized representative has signed the approved informed consent\n\nExclusion Criteria\n\nSubjects meeting any of the following criteria will be considered not eligible for enrollment in this study:\n\n1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires\n2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product\n3. History of previous synthetic, biologic or fascial sub-urethral sling\n4. Pregnancy or plans for future pregnancy\n5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.\n6. Current genitourinary fistula or urethral diverticulum\n7. Reversible cause of incontinence (i.e. drug effect)\n8. Contraindication to surgery",{"count":97,"type":20},195,"The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).",[24],[101,27],"Gynecare TVT ABBREVO® Continence System",{"date":62,"type":33},{"date":104,"type":33},"2021-09-09",{"date":106,"type":20},"2038-12-31",{"name":39,"class":40},""]