Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Not Applicable

Completed

• Conditions: Small Bowel Disease; Inflammatory Bowel Disease

• Registration Number: NCT01088646
• Lead Sponsor: Medtronic - MITG

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2012-03-27
• Results First Submitted QC: 2012-04-03
• Results First Posted: 2012-05-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System	up to 7 days	The number of capsules that successfully were in the duodenum as indicated by video images

Secondary Outcome Measures

Name	Time	Method
Physician's Subjective Assessment of the Ease of Capsule Placement	7 days	The physician was required to assess the ease of use while answering a designated questionnaire.; In addition, qualitative analysis was reformed with regard to all the open questions.

Trial Locations

Locations (3)

Alabama Digestive Disorders Center, P. C.; 🇺🇸 Huntsville, Alabama, United States

RANY -Research Associates of New York (NY Gastroenterology Associates); 🇺🇸 New York, New York, United States

Alabama Liver and Digestive Specialists; 🇺🇸 Montgomery, Alabama, United States