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

September 30, 2020 updated by: Medtronic - MITG
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Alabama Digestive Disorders Center, P. C.
      • Montgomery, Alabama, United States, 36116
        • Alabama Liver and Digestive Specialists
    • New York
      • New York, New York, United States, 10021
        • RANY -Research Associates of New York (NY Gastroenterology Associates)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (ESTIMATE)

March 17, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD-300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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