Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

NCT01269372 | Completed Results

• 1 other identifier: MA-203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy. This study will also use to evaluate the administrative feasibility and data management of study design.

Conditions

Colorectal Lesions

Keywords

polyps; capsule endoscopy; colonoscopy

Outcome Measures

Primary Outcomes (2)

• Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity

  PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

  Up to 6 weeks

• Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity

  PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

  Up to 6 weeks

Secondary Outcomes (2)

• Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity

  Up to 6 weeks

• Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity

  Up to 6 weeks

Study Arms (1)

PillCam Colon 2 and Standard Colonoscopy

OTHER

All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy.

Device: PillCam Colon 2; Device: Colonoscopy

Interventions

PillCam Colon 2 DEVICE

Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.

PillCam Colon 2 and Standard Colonoscopy

Colonoscopy DEVICE

The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.

PillCam Colon 2 and Standard Colonoscopy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 50 - 75 years of age, and an appropriate candidate for polyp screening.
• Subject received an explanation about the nature of the study and agrees to provide written informed consent.

You may not qualify if:

• Subject has a history of colorectal cancer
• Subjects with history of any positive colon assessment (including CT, colonoscopy, sigmoidoscopy etc.),
• Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) \< 5 years.
• Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
• Subject is suspected or diagnosed with familial adenomatous polyposis.
• Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer.
• Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
• Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety
• Subject is suspected or diagnosed with bowel obstruction.
• Subject has dysphagia or any swallowing disorder.
• Subject has congestive heart failure.
• Subject has Diabetes.
• Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months or other 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 has any allergy or other known contraindication to the medications used in the study.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

MeSH Terms

Conditions

Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This was a feasibility study, in accordance with the definition of a feasibility study within the ACT checklist. The feasibility study was used as preparation to study pivotal study number MA- 204 NCT01372878 which has results posted on CT.gov.

Results Point of Contact

• Title: Hilla Debby/ Director of Clinical Affairs
• Organization: Givenimaging

hila.debby@medtronic.com

97299077740

Study Officials

• Douglas Rex, Prof.

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-07

Locations

US (1)