NaviCam 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.
Study 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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Safety of patency capsule — 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 — 30 hours The percentage of patients that successfully pass the Patency capsule within 30 hours.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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