PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

NCT00604162 | Completed Phase 3 Results

• 1 other identifier: MA-53
• Study Type: interventional
• Target: 332
• Locations: 5 countries
• Sites: 7

Brief Summary

To see if PillCam COLON will demonstrate diagnostic yield \>80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

Conditions

Colonic Diseases

Keywords

Suspected colonic disease; Known colonic disease

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies

  The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.

  1 day

• Number of Participants With Indicated Lesions Detected by Standard Colonoscopy

  Since the standard colonoscopy is the "gold standard" to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger.

  1 day

• Sensitivity of Capsule Endoscopy for Indicated Lesions

  Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.

  1 day

• Specificity of Capsule Endoscopy for Indicated Lesions

  Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.

  1 day

Secondary Outcomes (5)

• Percent of Participants With Scoring Index 3 or 4

  1 day

• Number, Type and Severity of Adverse Events

  Within 7 days

• Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy

  within 7 days

• Percentage of Excreted Colon Capsules

  Within 7 days

• Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)

  within 7 days

Study Arms (1)

PillCam COLON and Colonoscopy

EXPERIMENTAL

Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy.

Device: PillCam COLON; Procedure: Standard colonoscopy

Interventions

PillCam COLON DEVICE

The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.

PillCam COLON and Colonoscopy

Standard colonoscopy PROCEDURE

Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.

PillCam COLON and Colonoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject was referred for 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 Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
• Any subject ≥ 18 years of age with:
• Positive findings in the colon on a GastroIntestinal (GI) radiographic study
• Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
• Suspected or known ulcerative colitis

You may not qualify if:

• Subject has dysphagia
• Subject has congestive heart failure
• Subject has renal insufficiency
• Subject is known or is suspected to suffer from intestinal obstruction.
• Chronic use of laxatives
• Subject has a cardiac pacemakers or other implanted electro medical devices.
• Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
• 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 \< 18 years
• Subject suffers from life threatening conditions
• Subject is currently participating in another clinical study
• Subject has known slow gastric emptying time

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (7)

CHU Lyon

Lyon, France

Location

CHU Nancy

Nancy, France

Location

Evangelisches Krankenhaus

Düsseldorf, Germany

Location

AK Altona

Hamburg, Germany

Location

Ospedale Gemelli

Rome, Italy

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

St.Marks&Northwick Park hospital

Harrow, United Kingdom

Location

Related Publications (1)

• Van Gossum A, Munoz-Navas M, Fernandez-Urien I, Carretero C, Gay G, Delvaux M, Lapalus MG, Ponchon T, Neuhaus H, Philipper M, Costamagna G, Riccioni ME, Spada C, Petruzziello L, Fraser C, Postgate A, Fitzpatrick A, Hagenmuller F, Keuchel M, Schoofs N, Deviere J. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009 Jul 16;361(3):264-70. doi: 10.1056/NEJMoa0806347.

  PMID: 19605831 RESULT

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Hila Debby
• Organization: Given Imaging

Hila.Debby@givenimaging.com

+972 4 9097774

Study Officials

• Jacques DEVIERE, M.D

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: January 30, 2008
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 1, 2019
• Results First Posted: February 18, 2011

Record last verified: 2010-08

Locations

ES (1); IT (1); FR (2); DE (2); GB (1)