Evaluation of PillCam® Express Capsule… | Clinical Trial

Key information

Conditions

Small Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases

Age range

2 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Digestive Disorders Center, P. C., Huntsville, Alabama, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PillCam® Express Capsule Endoscopy Delivery System

Device

The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts: a catheter, a syringe and the capsule holder. The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device. The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter.

Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded.

The PillCam® Express Capsule Endoscopy Delivery System is single-use, disposable and latex-free.

Primary outcomes

Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System

Time frame: up to 7 days

The number of capsules that successfully were in the duodenum as indicated by video images

Secondary outcomes

Physician's Subjective Assessment of the Ease of Capsule Placement

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Acronym: RD-300

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Mar 17, 2010
Registry last updated: Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed