Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Inflammatory Bowel Disease Clinical Trial

— RD-300  

Official title:

Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088646
• Other study ID #: RD-300
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Small Bowel Disease

Intervention

Device:
• PillCam® Express Capsule Endoscopy Delivery System
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.

Locations

Country	Name	City	State
United States	Alabama Digestive Disorders Center, P. C.	Huntsville	Alabama
United States	Alabama Liver and Digestive Specialists	Montgomery	Alabama
United States	RANY -Research Associates of New York (NY Gastroenterology Associates)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System	The number of capsules that successfully were in the duodenum as indicated by video images	up to 7 days
Secondary	Physician's Subjective Assessment of the Ease of Capsule Placement	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.	7 days