[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tela Bio Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100603367","effectiveness-and-safety-of-ovitex-prs-in-breast-reconstruction-100603367",false,"NCT07135596","Effectiveness and Safety of OviTex® PRS in Breast Reconstruction","Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation","RESTORE","Inclusion Criteria:\n\n1. Patient is a female between the ages of 22 - 75, inclusive, at the time of enrollment (e.g. date of index surgical procedure);\n2. Patient is planned for a first-time immediate unilateral or bilateral DTI pre-pectoral breast reconstruction following mastectomy for cancer or as cancer prophylaxis;\n3. Patient is not a current cigarette smoker;\n4. Patient is willing and able to voluntarily sign the IRB approved Subject Informed Consent Form;\n5. Patient is willing and able to comply with the study requirements including completion of required follow-up visits, subject questionnaires, clinic evaluations, and photographs.\n\nExclusion Criteria:\n\n1. Patient has a BMI \\\u003C 18.5 or \\> 35;\n2. Patient is undergoing radical mastectomy;\n3. Breast reconstruction plan includes hybrid implant coverage using another type of mesh (synthetic or ADM) or another autologous treatment such as large latissimus flap, abdominal flap or similar;\n4. Breast reconstruction plan includes a custom sized breast implant, permanent breast implant greater than 800cc, and\u002For a permanent breast implant that is not FDA approved for use in breast reconstruction;\n5. Patient has undergone prior breast reconstruction, breast augmentation, mastopexy, or breast reduction surgeries (not including breast biopsy);\n6. Patient is undergoing delayed reconstruction;\n7. Patient has received neo-adjuvant radiation to the chest (including any previous history of whole breast radiation or mantle radiation);\n8. Patient has received neo-adjuvant chemotherapy within the 4 weeks prior to enrollment;\n9. Patient has received Keytruda therapy or is planning to receive Keytruda therapy during study participation;\n10. Patient has uncontrolled Type I or Type II diabetes (HbA1C \\>7%);\n11. Patient is pregnant or planning to become pregnant during study participation and up to 5 years from the index surgical procedure;\n\n    • If the subject is not post-menopausal, agree to take adequate birth control precautions during study participation;\n12. Patient has been diagnosed with a medical condition or is taking medications which are known to impact wound healing, weaken the body's natural resistance to disease, result in elevated postoperative risks, or may otherwise affect the validity of the study;\n13. Patient has a known sensitivity or allergy to poly(lactic-co-glycolic acid) (PLGA) or materials of ovine (sheep) origin;\n14. Patient is diagnosed with a bleeding disorder in which medication is not stopped within 2 weeks of the index procedure;\n15. Patient is currently diagnosed with drug or alcohol abuse or has a known history with relapse within the past 3 years;\n16. Patient is currently participating in another drug or device clinical trial;\n17. Patient is currently imprisoned.\n\nIntraoperative Exclusion Criteria\n\nAll subjects will be evaluated intraoperatively for the following exclusion criteria:\n\n1. Subject does not receive an immediate pre-pectoral direct-to-implant breast reconstruction;\n2. Study device will not be used during the procedure or a non-eligible device will be implanted.","FEMALE","22 Years","75 Years",{"count":21,"type":22},235,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.",[28],"Breast Reconstruction","RECRUITING","2026-05-29",{"date":32,"type":33},"2026-06-02","ACTUAL",{"date":35,"type":33},"2026-04-10",{"date":37,"type":22},"2034-06",{"name":39,"class":40},"Tela Bio Inc","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100422368","ventral-or-inguinal-hernia-robotically-repaired-with-ovitex-mesh-100422368","NCT04779918","Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh","A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix","BRAVOII","Inclusion Criteria:\n\n1. Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.\n2. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.\n3. The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.\n4. Subject meets CDC\u002FSSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.\n5. Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.\n6. Subject is able to complete Quality of Life (QoL) and pain questionnaires.\n7. Subject is at least 21 years old.\n8. Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.\n\nExclusion Criteria at Baseline:\n\n1. Subject has a BMI of \\> 40\n2. Subject meets CDC\u002FSSI Wound Classification Class IV (Dirty-Infected) criteria\n3. Subject is female and is pregnant or plans to become pregnant during the course of the study.\n4. Subject has a life expectancy of \\\u003C 2 years making it unlikely that the subject will successfully achieve two-year follow-up.\n5. Subject has recent history of drug or alcohol abuse (in last 3 years).\n6. Subject has an allergy to ovine-derived products.\n7. Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.\n8. Subject has a strangulated hernia.\n\nExclusion Criteria Intraoperative:\n\n1. Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.\n2. Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.",true,"ALL","21 Years",{"count":54,"type":22},160,[25],"This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.",[58,59],"Hernia, Ventral","Hernia, Inguinal",[61,62],"use of mesh","robotic hernia repair","2026-04-29",{"date":65,"type":33},"2026-05-05",{"date":67,"type":33},"2021-04-29",{"date":69,"type":22},"2029-12-30",{"name":39,"class":40},10,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":41},"100598332","evaluating-clinical-hiatal-hernia-outcomes-using-ovitex-100598332","NCT07070115","Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®","A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix","ECH2O2","Inclusion Criteria:\n\n1. Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable.\n2. Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.\n3. Patient is at least 22 years old at the time of surgery.\n4. Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).\n5. Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.\n\nExclusion Criteria (Baseline):\n\n1. Patient has a Body Mass Index (BMI) of ≥ 35.\n2. Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.\n3. Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).\n4. Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.\n5. Patient is a current nicotine user (including smokeless, vaporized, etc.)\n6. Patient has a history of illicit drug or alcohol abuse (in the last three years).\n7. Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).\n8. Patient has an allergy to barium.\n9. Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).\n10. Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.\n11. Patient has participated in another gastrointestinal (GI) clinical study within the past 30 days or is currently involved in another clinical study excluding observational and registry studies.\n12. Patient had previous surgery at the gastroesophageal junction.\n13. Patient had a prior hiatal hernia repair.\n14. Patient has an incarcerated hernia that requires emergent intervention.\n15. Patient is a prisoner.\n\nExclusion Criteria (Intra-operative):\n\n1. Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.\n2. Surgery requires the use of an additional mesh device or a pledget for reinforcement.\n3. Surgery includes the use of an anti-reflux implantable device (LINX, etc.).\n4. Surgery performed as an open procedure.\n5. Patient has a condition, which in the Investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's participation in the study.",{"count":81,"type":22},173,[25],"This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.",[85],"Hiatal Hernia",[87,88,89],"hiatal","hernia","reinforced tissue matrix","2026-02-05",{"date":92,"type":33},"2026-02-09",{"date":94,"type":33},"2025-07-25",{"date":96,"type":22},"2032-07-31",{"name":39,"class":40},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":19,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100495872","a-retrospective-assessment-of-ovitex-prs-ovitex-100495872","NCT05736848","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","PRS","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.","18 Years",{"count":108,"type":22},200,"OBSERVATIONAL","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.",[112],"Reconstructive Surgical Procedures","2025-08-14",{"date":115,"type":33},"2025-08-15",{"date":117,"type":33},"2022-09-27",{"date":119,"type":22},"2026-12-31",{"name":39,"class":40},11,""]