A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 16
- 主要终点
- Performance of the PrevisEA device
研究概览
简要总结
PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later.
The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 90 years
- •Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
- •Segmental ileocolic resection with or without diversion
- •Segmental colon resection with or without diversion
- •Segmental coloproctectomy with or without diversion
- •Low anterior resection with or without diversion
- •Abdominoperineal resection
- •Total abdominal colectomy with or without diversion
- •Proctocolectomy with or without end ileostomy or diversion
- •Closure of end colostomy (Hartmann's reversal)
排除标准
- •Allergies to any of the device components (i.e., adhesive)
- •Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
- •Patients undergoing:
- •Small bowel resection without colonic resection
- •Transanal proctectomy without transabdominal approach
- •Perineal proctosigmoidectomy
- •Closure of loop colostomy or ileostomy
- •Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection
研究组 & 干预措施
PrevisEA device
The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants.
干预措施: PrevisEA device (Device)
结局指标
主要结局
Performance of the PrevisEA device
时间窗: 1-14 days
The performance (accuracy) of the device in predicting development of GII will be assessed through evaluation of the primary outcome measures of sensitivity and specificity for the device.
次要结局
- Positive predictive value (PPV)(1-14 days)
- Overall percent agreement (OPA)(1-14 days)
- Negative predictive value (NPV)(1-14 days)