NCT00481416

Brief Summary

The purpose of the study is to access the accuracy of the PillCam Eso capsule in identifying the presence of suspected esophageal disease in patients undergoing surveillance or screening for esophageal disease by standard endoscopy

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Shorter than P25 for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

July 31, 2019

Status Verified

June 1, 2006

First QC Date

May 30, 2007

Last Update Submit

July 29, 2019

Conditions

Esophageal Varices

Keywords

Esophageal VaricesPillCam EsoCapsule EndoscopyGiven ImagingInscope

Interventions

PillCam EsoDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has prior endoscopic confirmation of esophageal varices and is undergoing surveillance endoscopy or
  • Patient has sign/symptoms of chronic liver disease, without previous diagnosis of esophageal varices,with clinical indication to undergo esophagoscopy (or EGD)

You may not qualify if:

  • Patient has difficulty swallowing
  • Patient has known Zenker's Diverticulum
  • Patient went through previous endoscopic treatment of esophageal varices
  • Patient is known or is suspected to suffer from intestinal obstruction
  • Patient has a cardiac pacemaker or other implanted electro medical device
  • Female patient is pregnant
  • Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
  • Patient has had a prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or uncomplicated cholecystectomy)
  • Patient has any condition, which precludes compliance with study and/or device instructions
  • Patient suffers from life threatening conditions
  • Patient is currently participating in another clinical study -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mayo Clinic Hospital

Scottsdale, Arizona, 85259, United States

Location

Minnesota Gastroenterology Associates

Plymouth, Minnesota, 55446, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239-3098, United States

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Rambam Medical Center

Haifa, Israel

Location

Related Links

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Glenn M Eisen, MD

    OHSU Portland, OR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

December 1, 2004

Study Completion

January 1, 2005

Last Updated

July 31, 2019

Record last verified: 2006-06

Locations

AU(1)IL(1)US(3)