NCT00440791

Brief Summary

This multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

Geographic Reach
2 countries

7 active sites

Status
terminated

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

June 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 31, 2019

Status Verified

August 1, 2007

First QC Date

February 26, 2007

Last Update Submit

July 29, 2019

Conditions

Colonic Diseases

Keywords

Coloncolonic diseasecapsule endoscopySuspected or known colonic disease

Interventions

PillCam Colon capsule endoscopyDEVICE

Eligibility Criteria

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

You may qualify if:

  • Subject was referred for standard colonoscopy for one of the following reasons:
  • Subjects over 50 years of age with one or more of the following clinical symptoms:
  • rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits
  • Any subject over 18 years of age with:
  • Positive findings in the colon on a GI radiographic study (e.g., CT colonography, air-contrast barium enema, abdominal/pelvic CT scan)
  • Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 5 years since last colonoscopy or no sooner than 3 years prior to enrollment date as long as their prior colonoscopy revealed at least one of the following high risk conditions: multiple (greater than 3)adenomas, large adenoma (greater than 1 cm) , adenomas with a villous component, adenoma with high grade dysplasia.
  • Suspected or known ulcerative colitis

You may not qualify if:

  • The presence of any of the following will exclude a subject from study enrollment:
  • Subject has dysphagia
  • Subject has congestive heart failure
  • Subject has renal insufficiency
  • Subject is known or is suspected to suffer from intestinal obstruction.
  • Subject has a cardiac pacemaker or other implanted electro medical devices.
  • Subject is pregnant
  • Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  • Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
  • Subject has any condition, which precludes compliance with study and/or device instructions.
  • Age less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Minnesota Gastroenterology

Minneapolis, Minnesota, 55446, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Private Medical Facility

New York, New York, 10128, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239-3098, United States

Location

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Colonic Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Douglas Rex, M.D.

    Indiana University Hospital

    PRINCIPAL INVESTIGATOR

  • Glenn Eisen, M.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Rami Eliakim, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

  • Jonathan Leighton, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Chris Gostout, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Elizabeth Rajan, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Blair Lewis, MD

    Private Medical Facility

    PRINCIPAL INVESTIGATOR

  • S Ketover, MD

    Minnesota Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

June 1, 2006

Study Completion

July 1, 2007

Last Updated

July 31, 2019

Record last verified: 2007-08

Locations

IL(1)US(6)