NaviCam Patency Capsule to Verify Gastrointestinal Patency

N/ANot Yet RecruitingNCT07649720

AnX Robotica Corp.25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Intestinal Stricture Crohn Disease NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy Abdominal Pain

Interventions

NaviCam Patency CapsuleDEVICE

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (1)

Digestive Health Services

Downers Grove, Illinois, United States

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.

Time frame: 30 hours

Efficacy of patency capsule

The percentage of patients that successfully pass the Patency capsule within 30 hours.

Time frame: 30 hours

Central Contacts

Tim Thomas, RAC

CONTACT

770-480-2911 tim.thomas@anxrobotics.com

Data from ClinicalTrials.gov

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