Safe Anastomosis Feasibility Study: a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac+ Colorectal Anastomosis Protection Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SafeHeal Inc
- 入组人数
- 27
- 试验地点
- 14
- 主要终点
- To measure the incidence of serious adverse events related to using the device
研究概览
简要总结
A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer
详细描述
A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
Colovac+ is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years of age or older)
- •Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.
- •Willingness to comply with Clinical Investigation Plan-specific treatment and study visits and to sign a written Informed Consent Form
排除标准
- •- Preoperatively :
- •Patient with inflammatory bowel disease
- •Known allergy to nickel or other components of the Colovac+ kit
- •Pregnant or nursing female subject
- •Concomitant major surgical procedure in combination with Colorectal resection (i.e. hepatectomy)
- •Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:
- •COVID-19 positive (active infection) based on test within 72 hours prior to surgery
- •Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1
- •Immunodeficiency (CD4+ count < 500 CU MM)
- •Systemic steroid therapy within the past 6 months
- •Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
- •Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
- •Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
- •Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
- •Severe Malnutrition defined as 10% weight loss within 3 months prior to enrollment.
- •The subject is currently participating in another investigational drug or device study
- •Intraoperatively :
- •Anastomosis placement at more than 10cm from anal margin
- •Occurrence of any of the following during the colorectal surgery:
- •Blood loss (>750 cc)
- •Blood transfusion
- •Any new sign of ischemia
- •Positive air leak test - requiring re intervention on the anastomosis
- •Inadequate bowel preparation
- •Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device
研究组 & 干预措施
Colovac
Patients receive Colovac device during colorectal surgery
干预措施: Colovac (Device)
结局指标
主要结局
To measure the incidence of serious adverse events related to using the device
时间窗: 3 months
The primary endpoint will be a measurement of SAEs probably related or causaly related to the use of the investigational device, to the index surgery in this clinical trial.
次要结局
- To evaluate the integrity of the anchoring site during the device retrieval using endoscopy.(10 days)
- To evaluate the integrity of the anastomosis before the device retrieval using fluoroscopy(10 days)
- To measure the number of participants with evidence of absence of feces between the sheath and the colonic wall before device retrieval(10 days)
- To measure the rate of ostomy avoidance(3 months)
- To measure on a scale of 1 to 5 rated by the surgeon the ease of device introduction, positioning and endoscopic retrieval(10 days)
- To evaluate the integrity above the anchoring site during the device retrieval using endoscopy.(10 days)
- To evaluate the integrity of the anastomosis after the device retrieval using fluoroscopy(10 days)
- To measure the patient tolerability of the device using a patient questionnaire(10 days)
- To evaluate the occurrence of clinical anastomotic leakage(3 months)
- To evaluate the clinically significant migration rate(10 days)
- To measure the average procedure time(1 day)