A Prospective, Single Center Clinical Trial Assessing the Efficacy and Safety of the NaviCam Patency Capsule to Verify Gastrointestinal Patency
AnX Robotica Corp.
Summary
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.
Description
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 disso…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclus…
Interventions
- DeviceNaviCam Patency Capsule
The NaviCam Patency Capsule is an accessory to the NaviCam capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the NaviCam capsule in patients with known or suspected strictures.
Location
- Digestive Health ServicesDowners Grove, Illinois