Evaluation of PillCam™ Colon 2 in Visualization of the Colon

NCT01087528 | Completed Results

• 1 other identifier: MA-202
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.

Conditions

Colonic Diseases; Bowel Diseases

Keywords

Colonic Diseases; bowel diseases; large bowel diseases

Outcome Measures

Primary Outcomes (2)

• Accuracy of Detection in Patients With Colonic Polyps - Sensitivity

  The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.

  within 7 days

• Accuracy of Detection in Patients With Colonic Polyps - Specificity

  The accuracy parameters (i.e. specificity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.

  within 7 days

Secondary Outcomes (3)

• Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions

  within 7 days

• Percent of Participants With Scoring Index 3 or 4 (Good or Excellent)

  within 7 days

• Capsule Excretion Time

  within 7 days

Study Arms (1)

1

EXPERIMENTAL

Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.

Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule

Interventions

PillCam™ (Capsule Endoscopy) Colon 2 capsule DEVICE

Medical Device

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between the ages of 18-70
• Subject was referred to colonoscopy for at least one of the following reasons:
• Colorectal cancer screening for age ≥60
• Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits for age ≥50
• Positive findings in the colon (e.g. Polyp ≥10mm)
• Personal history of significant polyps( ≥6mm )that were removed at least 3 years ago (3 years and above)

You may not qualify if:

• Age \> 70 years
• Subject has dysphagia or any swallowing disorder
• Subject has congestive heart failure
• Subject has known renal disease
• Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator
• Subject has any allergy or other known contraindication to the medications used in the study
• 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 a cardiac pacemaker or other implanted electro medical device.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, incomplete colonoscopies due to obstructions or NSAID enteropathy,
• Subject with gastrointestinal motility disorders
• Subject has known delayed gastric emptying
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are either pregnant at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
• Subject suffers from life threatening conditions

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (4)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Digestive Care, Inc.

Beavercreek, Ohio, 45440, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Related Publications (1)

• Morgan DR, Malik PR, Romeo DP, Rex DK. Initial US evaluation of second-generation capsule colonoscopy for detecting colon polyps. BMJ Open Gastroenterol. 2016 May 3;3(1):e000089. doi: 10.1136/bmjgast-2016-000089. eCollection 2016.

  PMID: 27195129 DERIVED

MeSH Terms

Conditions

Colonic Diseases; Intestinal Diseases

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Hilla Debby/Director of clinical affairs
• Organization: Givenimaging

hila.debby@givenimaging.com

972490977740

Study Officials

• Douglas Rex, Dr.

  Division of Gastroenterology, Indiana University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 22, 2020
• Results First Posted: June 8, 2012

Record last verified: 2020-09

Locations

US (4)