A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tela Bio Inc
- 入组人数
- 160
- 试验地点
- 20
- 主要终点
- Early surgical site occurrences or wound related events
研究概览
简要总结
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.
详细描述
This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent.
- •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.
- •Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
- •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.
- •Subject is able to complete Quality of Life (QoL) and pain questionnaires.
- •Subject is at least 21 years old.
- •Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.
- •Exclusion Criteria at Baseline:
- •Subject has a BMI of > 40
- •Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
- •Subject is female and is pregnant or plans to become pregnant during the course of the study.
- •Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
- •Subject has recent history of drug or alcohol abuse (in last 3 years).
- •Subject has an allergy to ovine-derived products.
- •Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
- •Subject has a strangulated hernia.
- •Exclusion Criteria Intraoperative:
- •Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
- •Subject unable to receive OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent time of surgery.
排除标准
- 未提供
研究组 & 干预措施
OviTex Reinforced Tissue Matrix
This is a single-arm study. All study subjects will receive OviTex.
干预措施: OviTex Reinforced Tissue Matrix (Device)
结局指标
主要结局
Early surgical site occurrences or wound related events
时间窗: occurring within the first 3 months of the ventral or inguinal hernia repair
Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site
Early post-operative complications
时间窗: occurring within the first 3 months of the ventral or inguinal hernia repair.
Incidence of other early post-operative complications
次要结局
- Late surgical site occurrences or wound related events(occurring > 3 months after index surgery)
- Patient Reported Outcomes(Assessed at day 30, day 90, 12 months, and 24 months post-op)
- Late post-operative complications(occurring > 3 months after index surgery.)
- Hernia Recurrence(at post-operative day 90 and months 12 and 24)