PumaRx Registry Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: RenovoCath®.
- Кому может быть актуально
- Состояния в реестре: Solid Tumors. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство RenovoCath®
Intra-arterial catheter delivery of chemotherapy agents for the collection of real-world data.
Первичные конечные точки
- Safety of RenovoCath® as assessed by the number of participants experiencing adverse events related to the chemotherapy agents administered using RenovoCath. [Срок оценки: From the time of the first treatment, until 30 days after the last treatment]
- Performance of RenovoCath® as assessed by the number of participants experiencing adverse events related to the inter-arterial drug delivery procedure. [Срок оценки: From the time of the first treatment, until 30 days after the last treatment]
Вторичные конечные точки (3)
- Overall Survival [Срок оценки: 24 months from date of first treatment with IA]
- Tumor Response Rate [Срок оценки: 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 [Срок оценки: 6 months from the date of the first IA treatment]
Критерии участия
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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 3 центра
- Baptist Health South Florida — Coral Gables
- University of Pennsylvania Medical Center — Pittsburgh
- The University of Vermont Medical Center — Burlington
Идентификаторы
NCT: NCT06805461 · RR5