Evaluation of PillCam™ Colon 2 in Visualization of the Colon

NCT01063231 | Completed Phase 3

• 1 other identifier: MA-201
• Study Type: interventional
• Target: 119
• Locations: 7 countries
• Sites: 8

Brief Summary

Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.

Conditions

Colonic Diseases; and Large Bowel Diseases

Keywords

Colonic Diseases; bowel diseases

Outcome Measures

Primary Outcomes (1)

• Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps ≥6mm and ≥10 mm as compared to conventional colonoscopy

  within 7 days

Secondary Outcomes (6)

• Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy

  within 7 days

• Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy

  within 7 days

• Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos

  within 7 days

• Capsule transit time within stomach, small bowel and colon based on Rapid videos

  within 7 days

• Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy

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

You may qualify if:

• Subject is between the ages of 18-80
• Subject was referred to colonoscopy for at least one of the following reasons:
• Colorectal cancer screening for age ≥50
• 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 polyps that were removed at least 3 years ago (3 years and above)

You may not qualify if:

• Subject has dysphagia or any swallowing disorder
• Subject has congestive heart failure
• Subject has high risk of renal insufficiency associated with the use of sodium phosphate
• 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
• Subject currently participating in another clinical study

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (8)

Hospital Erasme - Gastro-Enterologie

Brussels, 1070, Belgium

Location

Chef de Service dHepato-Gastro-Enterologie et dAssistance Nutritionnelle CHU Nantes

Nantes, 44093, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Ospedale Gemelli,ENDOSCOPIA DIGESTIVA

Roma, 00168, Italy

Location

Academic Medical Center University of Amsterdam

Amsterdam, 1100, Netherlands

Location

Clinica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Malmo University Hospital

Malmo, Sweden

Location

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

Study Officials

• Guido Costamagna, Prof.

  Ospedale Gemelli

  PRINCIPAL INVESTIGATOR

• Guido Costamagna, Prof

  Ospedale Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2009
• First Posted: February 5, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 31, 2019

Record last verified: 2010-11

Locations

ES (1); IT (1); FR (2); DE (1); SE (1); BE (1); NL (1)