PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon (MA-53)

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

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

Study Overview

• Status: Completed
• Conditions: Colonic Diseases
• Intervention / Treatment: Device: PillCam COLON; Procedure: Standard colonoscopy

Detailed Description

The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.

This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • CHU LYON
  • Nancy, France
    • Chu Nancy
• Germany
  • Dusseldorf, Germany
    • Evangelisches Krankenhaus
  • Hamburg, Germany
    • AK Altona
• Italy
  • Rome, Italy
    • Ospedale Gemelli
• Spain
  • Pamplona, Spain
    • Clinica Universitaria de Navarra
• United Kingdom
  • Harrow, United Kingdom
    • St.Marks&Northwick Park hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PillCam COLON and Colonoscopy; 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; 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.; Procedure: Standard colonoscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants With Scoring Index 3 or 4	Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: poor cleansing level (Large amount of fecal residue.); fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.); good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.); excellent cleansing level (No more than small bits of adherent feces.)	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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Jacques DEVIERE, M.D, Hopital Erasme

Publications and helpful links

General Publications

• 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. Erratum In: N Engl J Med. 2009 Sep 17;361(12):1220. Navas, Miguel Munoz [corrected to Munoz-Navas, Miguel].

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Suspected colonic disease; Known colonic disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: MA-53