About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
NaviCam Patency Capsule
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Safety of patency capsule
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
The percentage of patients that successfully pass the Patency capsule within 30 hours.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: