Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 19
- 主要终点
- Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit.
研究概览
简要总结
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.
In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
详细描述
Although the majority of polyps are non-malignant, it is known that the risk of malignancy increases with polyp size, with polyps < 10 mm having < 1% risk of cancer, polyps of 10 mm having a 10% risk of cancer and polyps of 20 mm having a greater than 10% risk of cancer. It is also understood that a polyp of < 1 cm takes approximately 10 years to transform into invasive colorectal carcinoma. Therefore, adenomas greater than 5 mm are normally treated. Polyps with tethered bases resulting from scarring are often the most challenging to resect endoscopically. The scarring can be caused by previous attempts at resection, previous deep biopsies, or tattoos placed too closely. These polyps often do not lift and can be impossible to snare even when stiff snares are used. Endoscopic submucosal dissection (ESD) and knife-assisted resection (KAR) are techniques that have been shown effective in the management of scarred polyps, however these techniques have not been widely adopted in the West. Argon plasma coagulation has been more commonly used to ablate adenomatous tissue in scarred polyps but this technique does not allow for the histological assessment of the scarred polyp and is less effective than ESD. The EndoRotor provides a technique whereby the lesion can be effectively removed without adjunct procedures with collection of tissue for histological assessment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥18 to ≤85 years.
- •At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.
- •Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.
- •Favorable anatomy that allows the investigator to access the lesion.
- •Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.
- •Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.
排除标准
- •Inability to give informed consent.
- •Subject age is <18 years of age or >85 years of age.
- •Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.
- •Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality
- •Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.)
- •Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for < 1 week.
- •Inability to undergo a procedure under propofol sedation or General Anesthesia.
- •Female patients who are known to be pregnant.
- •Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
- •Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
- •Subject is participating in another study of a device, medication, biologic, or other agent within 90 days and could, in the opinion of the investigator, impact the results of this study.
- •Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and participating in evaluations pre- and post-treatment.
结局指标
主要结局
Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit.
时间窗: Index Procedure through 90 Day Post Procedure Follow-up Visit
Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit.
时间窗: Index Procedure through 90 Day Post Procedure Follow-up Visit
次要结局
- Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.(Index Procedure)
- Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.(90-day follow-up visit)
- Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit.(90-day follow-up visit)
- Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).(90-day follow-up visit)