Evaluation of PillCam® Express Capsule Endoscopy Delivery System (RD-300)

Medtronic

Status

Completed

Conditions

Small Bowel Disease

Inflammatory Bowel Disease

Treatments

Device: PillCam® Express Capsule Endoscopy Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01088646

RD-300

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.

Full description

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 2001 for small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies.

Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the device description section.

This study is designed to evaluate the performance and safety of the Capsule Endoscopy Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD) endoscopy

Enrollment

25 patients

Sex

All

Ages

2 to 85 years old

Volunteers

No Healthy Volunteers

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