A Multi-Center, Observational, Post-Marketing, Registry Study Following Patients With Solid Tumors Treated With Therapeutic Agents Via Localized Intra-Arterial Delivery Using the RenovoCath® Catheter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- RenovoRx
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Safety of RenovoCath® as assessed by the number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.
研究概览
简要总结
This study is a multicenter, observational, post-marketing, registry study designed to track the safety and performance of the RenovoCath® device and assess survival outcomes in patients diagnosed with solid tumors who are treated with localized intra-arterial (IA) delivery of therapeutic agents to solid tumors using the RenovoCath® catheter.
详细描述
This study will enroll patients diagnosed with solid tumors who are willing to participate in the registry and meet the study enrollment criteria. Participants will be treated with therapeutic agents using RenovoCath® for the approved intended use according to the current country-specific Instructions for Use (IFU). Participants will be followed for survival outcome. Patients may chose to consent to participation in the registry before, during, or after treatment with the RenovoCath® device.
This observational post-marketing registry study is intended to track the safety and performance of the RenovoCath® device and assess patient survival / clinical outcomes of RenovoCath® in a real-world, clinical, observational setting when used for targeted delivery of therapeutic agents. Up to 1000 patients will be enrolled at up to an estimated 100 sites. Each patient participating in the registry study will have medical record retrievals including past data as of the time of their initial diagnosis through all localized IA administrations of therapeutic agent(s) using RenovoCath®, with continued record retrieval through the end of patient follow-up to record mortality rates. Patient data collection will include prior treatment history. Patients and/or their families will be contacted periodically after the treatment(s) to assess survival. It is anticipated that each participating patient's records will be retrieved approximately four times throughout the course of their treatment and follow-up, or retrospectively should patents decide to participate in the registry upon the completion of their treatment or during follow-up. This registry study is expected to continue for six years from study commencement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Male and female patients who have been diagnosed with solid tumor cancers and are at least 18 years of age at the time of the first IA procedure
- •Patients willing to provide informed consent and HIPAA release for use of their relevant medical records
排除标准
- 未提供
结局指标
主要结局
Safety of RenovoCath® as assessed by the number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.
时间窗: From the time of the first treatment, until 30 days after the last treatment
Number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath.
Performance of RenovoCath® as assessed by the number of participants experiencing adverse events related to the inter-arterial drug delivery procedure.
时间窗: From the time of the first treatment, until 30 days after the last treatment
Track the performance of RenovoCath® in a real-world setting delivering a variety of therapeutic agents
次要结局
- Overall Survival(24 months from date of first treatment with IA)
- Tumor Response Rate(24 months from date of first treatment with IA)
- Number of participants who are downstaged and have their tumor resected after IA treatment with RenovoCth(6 months from the date of the first IA treatment)
