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Evaluation of PillCam® Express Capsule Endoscopy Delivery System

NCT01088646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-10-22

Study results available
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Summary

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

Conditions

Interventions

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 Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors.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

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Jonathan Leighton, MD · Mayo Clinic

  • Peter Legnani, MD · Private Practice New York, New York

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01088646 on ClinicalTrials.gov