[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05736848":3,"trial-entities:NCT05736848":160,"trial-summary:NCT05736848":164},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":42,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":22,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":153,"overall_officials":154,"references":158,"see_also_links":159},"NCT05736848","TB2022.01.02","A Retrospective Assessment of OviTex PRS (OviTex)","A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction","ACTIVE_NOT_RECRUITING","2026-12-31","2026-08","2026-08-18","2022-09-27","Tela Bio Inc","INDUSTRY",false,"The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.","This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.",[19],"Reconstructive Surgical Procedures",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},200,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"otherNames":32},"DEVICE","OviTex® PRS","OviTex® PRS is a reinforced tissue matrix intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.",[33,34,35,36],"OviTex PRS Permanent - Pre-pectoral","OviTex PRS Permanent - Sub-pectoral","OviTex PRS Resorbable - Pre-pectoral","OviTex PRS Resorbable - Sub-pectoral",[38],{"measure":39,"description":40,"timeFrame":41},"The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.","Retrospective - Prospective assessment","24 months",[43,46,48,51,53],{"measure":44,"description":40,"timeFrame":45},"Time to Expander\u002FImplant Exchange","24-months",{"measure":47,"description":40,"timeFrame":41},"Intraoperative Fill Volume \u002F Number and Volume of Fill Visits",{"measure":49,"description":50,"timeFrame":41},"Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score","Image aesthetic assessment",{"measure":52,"description":40,"timeFrame":45},"Independent assessment of breast ptosis as measured by the Rainbow Scale",{"measure":54,"description":40,"timeFrame":55},"Hospitalization length of stay","At procedure","FEMALE","18 Years","75 Years",{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\n1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.\n2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction.\n3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).\n\nExclusion Criteria:\n\n1. Patient received a textured permanent breast implant.\n2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.\n3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery.\n\nAdditional prospective inclusion criteria (if applicable):\n\n1\\. Patient agrees to return in-person for prospective portion including the completion of photographs.\n\nAdditional prospective exclusion criteria (if applicable):\n\n1\\. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.",[64,65],"ADULT","OLDER_ADULT",[67,76,83,91,99,107,115,122,130,138,146],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Aesthetic Surgery Center","Naples","Florida","34108","United States",{"lat":74,"lon":75},26.14234,-81.79596,{"facility":77,"city":78,"state":70,"zip":79,"country":72,"geoPoint":80},"Castrellon Aesthetic Surgery","South Miami","33143",{"lat":81,"lon":82},25.7076,-80.29338,{"facility":84,"city":85,"state":86,"zip":87,"country":72,"geoPoint":88},"Y Plastic Surgery","Alpharetta","Georgia","30005",{"lat":89,"lon":90},34.07538,-84.29409,{"facility":92,"city":93,"state":94,"zip":95,"country":72,"geoPoint":96},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":97,"lon":98},42.35843,-71.05977,{"facility":100,"city":101,"state":102,"zip":103,"country":72,"geoPoint":104},"Janineh Plastic Surgery","Rochester Hills","Michigan","48307",{"lat":105,"lon":106},42.65837,-83.14993,{"facility":108,"city":109,"state":110,"zip":111,"country":72,"geoPoint":112},"David L. Abramson, MD","Englewood","New Jersey","07631",{"lat":113,"lon":114},40.89288,-73.97264,{"facility":116,"city":117,"state":110,"zip":118,"country":72,"geoPoint":119},"Capital Health","Pennington","08534",{"lat":120,"lon":121},40.32844,-74.79072,{"facility":123,"city":124,"state":125,"zip":126,"country":72,"geoPoint":127},"Strong Memorial Hospital","Rochester","New York","14642",{"lat":128,"lon":129},43.15478,-77.61556,{"facility":131,"city":132,"state":133,"zip":134,"country":72,"geoPoint":135},"Plastic Surgery Consultants","Columbia","South Carolina","29201",{"lat":136,"lon":137},34.00071,-81.03481,{"facility":139,"city":140,"state":141,"zip":142,"country":72,"geoPoint":143},"Dermatology Associates of San Antonio\u002FBaptist Medical Center","San Antonio","Texas","78256",{"lat":144,"lon":145},29.42412,-98.49363,{"facility":147,"city":148,"state":141,"zip":149,"country":72,"geoPoint":150},"Houston Methodist The Woodlands Hospital","The Woodlands","77385",{"lat":151,"lon":152},30.15799,-95.48938,[],[155],{"name":156,"affiliation":84,"role":157},"Asaf Yalif, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":161,"biomarkers":163},[162],"Mammoplasty",[],{"nct_id":4,"found":165,"summary":166,"prompt_version":176},true,{"design":167,"status":168,"heading":169,"summary":170,"follow_up":171,"word_count":172,"commitments":173,"compensation":174,"drugs_mentioned":175},"This is an observational study, meaning researchers are looking at existing patient data rather than assigning treatments. It is a multi-center study, aiming to include 200 participants.","completed","Observational Study of OviTex PRS in Breast Reconstruction","This study is looking back at how safe OviTex® PRS (a reinforced tissue matrix used to support soft tissue) has been for patients who had it placed during breast reconstruction surgery. Researchers are specifically interested in patients who received an OviTex PRS Permanent or Resorbable implant as part of their implant-based breast reconstruction. The study will look at any relevant side effects (SAEs) that occurred within 24 months after the OviTex® PRS was implanted. You might be eligible if you are a woman between 18 and 75 years old who has already had this type of breast reconstruction. The study aims to enroll 200 participants, but its current status is unclear.","The study will look at side effects for up to 24 months after the OviTex® PRS was implanted.",111,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]