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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01088646
First received: March 15, 2010
Last updated: May 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention
Small Bowel Disease
Inflammatory Bowel Disease
 Device: PillCam® Express Capsule Endoscopy Delivery System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Number of Participants With Successful Capsule Placment Into the Duodenum Using Capsule Delivery System [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    The number of capsules that successfully were in the duodenum as indicated by video images

  • Percentage of Capsule Placement Success Using PillCam® Express Capsule Endoscopy Delivery System [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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    Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors.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.

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

  Eligibility

Ages Eligible for Study:   2 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088646

Locations
United States, Alabama
Alabama Digestive Disorders Center, P. C.
Huntsville, Alabama, United States, 35802
Alabama Liver and Digestive Specialists
Montgomery, Alabama, United States, 36116
United States, New York
RANY -Research Associates of New York (NY Gastroenterology Associates)
New York, New York, United States, 10021
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Jonathan Leighton, MD Mayo Clinic
Principal Investigator: Peter Legnani, MD Private Practice New York, New York
  More Information

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01088646     History of Changes
Other Study ID Numbers: RD-300
Study First Received: March 15, 2010
Results First Received: March 27, 2012
Last Updated: May 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
capsule endoscopy
small bowel disease
inflammatory bowel disease
Subjects indicated for EGD endoscopy

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013