Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Launched by MEDTRONIC - MITG · Mar 16, 2010

Keywords

ClinConnect Summary

Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery System is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope.

The PillCam™ SB capsule to be used in this study was cleared by the FDA in August...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 2 years
• • Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel
• Exclusion criteria:
• • Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation
• • Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
• • Presence of an electro-medical device (pacemaker or internal cardiac defibrillator)
• • Subject is pregnant
• • Subject is expected to undergo a MRI examination within 7 days after ingestion of the capsule
• • Subject has known allergy to conscious sedation medications
• • Subject or legal guardian is not able to provide written informed consent