NaviCam Patency Capsule to Verify Gastrointestinal Patency

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorAnX Robotica Corp.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • NaviCam Patency Capsule

    Device

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Single arm patency capsule evaluationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Efficacy of patency capsule

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

Time frame
30 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: