Abdominal Pain, Crohn Disease, Intestinal Stricture, NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy
Conditions
Brief 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.
Detailed 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 dissolvable passive capsule and will dissolve over time if not excreted.
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.
Sponsors
AnX Robotica Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Participants in this study will first swallow a patency capsule and then undergo an abdominal X-ray within 30 hours after swallowing the patency capsule to confirm if the capsule is still in the body. The goal of the patency capsule is to screen for strictures that may interfere with the passage of an endoscopy capsule at a later time.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTTim Thomas, RAC
PRINCIPAL_INVESTIGATORRockford G Yapp, MD
Digestive Health Services
Outcome results
None listed