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OpenTrials
Completed

NCT Number: NCT00604162

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.

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Key information

Conditions

Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Lyon, Lyon, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies

    Time frame: 1 day

    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.

  2. Number of Participants With Indicated Lesions Detected by Standard Colonoscopy

    Time frame: 1 day

    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.

  3. Sensitivity of Capsule Endoscopy for Indicated Lesions

    Time frame: 1 day

    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.

  4. Specificity of Capsule Endoscopy for Indicated Lesions

    Time frame: 1 day

    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.

Secondary outcomes

  1. Percent of Participants With Scoring Index 3 or 4

    Time frame: 1 day

    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.)

  2. Number, Type and Severity of Adverse Events

    Time frame: Within 7 days

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

    Time frame: within 7 days

  4. Percentage of Excreted Colon Capsules

    Time frame: Within 7 days

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

    Time frame: within 7 days

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: MA-53

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 30, 2008
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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