Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Performance: Number of Participants With Histological Evidence of Tumor Cell Capture
研究概览
简要总结
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is a female ≥18 years old.
- •Presents with a diagnosis of Stage IIIC ovarian cancer.
- •Presents with high-grade serous carcinoma.
- •Has one of the following:
- •Visible residual tumor ≤1 cm after primary tumor debulking surgery.
- •Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery.
- •Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery.
- •ECOG performance status of 0 or
- •Is willing to comply with required follow-up study visits.
- •Is willing and able to provide written informed consent.
排除标准
- •Has a life expectancy of <3 months.
- •Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating.
- •Will be receiving intraperitoneal chemotherapy.
- •Has undergone prior treatment with abdominal and/or pelvic radiotherapy.
- •Has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Presence of central nervous system or cerebral metastases.
- •Recurrent ovarian cancer.
- •Complete resection with no residual tumor after primary tumor debulking surgery.
- •Suboptimal resection with >1 cm residual tumor after primary or interval tumor debulking surgery.
- •Is simultaneously enrolled in another investigational study.
- •Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer.
- •Has a known hypersensitivity to carboplatin or paclitaxel.
- •Is concurrently using other antineoplastic agents.
研究组 & 干预措施
M-Trap
干预措施: M-Trap (Device)
结局指标
主要结局
Performance: Number of Participants With Histological Evidence of Tumor Cell Capture
时间窗: Time of device removal, an average of 13.3 months
Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
时间窗: 30 days
An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
时间窗: 6 months
The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites.
次要结局
- Safety: Number of Participants With Device-related Long-term Adverse Event Reporting(18 months)
- Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting(18 months)
- Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status(Time of recurrence, an average of 14.5 months)