A Prospective, Single Center Clinical Trial Assessing the Efficacy and Safety of the NaviCam Patency Capsule to Verify Gastrointestinal Patency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Safety of patency capsule
研究概览
简要总结
Participants included in this study will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm weather the capsule is still in the body.
详细描述
If the X-ray scan indicates that the capsule is not in the body or shows that the patency capsule is in the colonic area or if an intact patency capsule is found in the bowel movement, it proves that the intestine is patent, and the patient can undergo an examination using capsule endoscopy. If the X-ray scan shows that the capsule is still in the small bowel area, it indicates that there may be stricture(s) in the intestines, and then small bowel capsule endoscopy may not be performed.
The patency capsule is a disposable medical device composed of medicinal excipients in the shape of a dissolvable passive capsule and will dissolve over time if not excreted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected or known intestinal stricture (with medical history records, physical examination records, and imaging evidence within the last 6 months.
- •Patients suffering from Crohn's Disease
- •Patients with long-term use of non-steroidal anti-inflammatory drugs.
- •Patients with abdominal symptoms related to intestinal stricture.
- •Patients with chronic inflammatory diseases.
- •Patients with difficulty with balloon-assisted endoscopy (BAE).
- •Patients with a history of small bowel obstruction.
- •Patients with a history of intestinal resection surgery.
排除标准
- •Patients with esophageal obstruction or swallowing disorder diseases.
- •Patients who are ineligible for surgery or refuse to undergo any abdominal surgery.
- •Patients with known allergies or other contraindications or intolerance to the medications used in this study.
- •Patients with pacemakers or other implanted electronic devices such as cochlear implants, magnetic metal drug infusion pumps, neurostimulators.
- •Pregnant women
- •Patients currently enrolled in another drug or device clinical trial.
- •Other conditions deemed unsuitable for inclusion by the investigator.
研究组 & 干预措施
Single arm patency capsule evaluation
Participants will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm whether the capsule is still in the body.
干预措施: NaviCam Patency Capsule (Device)
结局指标
主要结局
Safety of patency capsule
时间窗: 30 hours
The number of patients successfully passing the Patency Capsule within 30 hours compared to the number of patients where the Patency Capsule dissolves in patients with strictures.
Efficacy of patency capsule
时间窗: 30 hours
The percentage of patients that successfully pass the Patency capsule within 30 hours.
次要结局
未报告次要终点