Solid Tumors
Conditions
Keywords
Intra-Arterial Catheter
Brief summary
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.
Detailed description
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.
Interventions
DEVICERenovoCath®
Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.
Sponsors
RenovoRx
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: 1. 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 2. Patients willing to provide informed consent and HIPAA release for use of their relevant medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of RenovoCath® as assessed by the number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath. | 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 24 months from date of first treatment with IA | Evaluate overall survival (OS) in patients diagnosed with solid tumors who undergo localized IA delivery of therapeutic agents via the RenovoCath® |
| Tumor Response Rate | 24 months from date of first treatment with IA | Assess tumor response, via imaging, in the primary site of application |
| 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 | The number of participants who received IA treatment with RenovoCath and later receive resection of their tumor |
Countries
United States
Contacts
CONTACTLeesa M Gentry
CONTACTNicolette G Keller
Outcome results
None listed