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

NCT ID: NCT01269372

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: DOUBLE

Study Groups

PillCam Colon 2 and Standard Colonoscopy

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

Group Type: OTHER

PillCam Colon 2

Intervention Type: 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.

Colonoscopy

Intervention Type: 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.

Interventions

PillCam Colon 2

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.

Intervention Type: DEVICE

Colonoscopy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is between 50 - 75 years of age, and an appropriate candidate for polyp screening.

2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion Criteria

1. Subject has a history of colorectal cancer

2. Subjects with history of any positive colon assessment (including CT, colonoscopy, sigmoidoscopy etc.),

3. Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) < 5 years.

4. 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.

5. Subject is suspected or diagnosed with familial adenomatous polyposis.

6. Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer.

7. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.

8. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety

9. Subject is suspected or diagnosed with bowel obstruction.

10. Subject has dysphagia or any swallowing disorder.

11. Subject has congestive heart failure.

12. Subject has Diabetes.

13. 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.

14. Subject has a cardiac pacemaker or other implanted electro medical device.

15. Subject has any allergy or other known contraindication to the medications used in the study.

16. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.

17. Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.

18. Subject with strictures, fistulas and/or chronic constipation.

19. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.

20. Subject with known gastrointestinal motility disorders.

21. Subject has known delayed gastric emptying.

22. Subject has any condition, which precludes compliance with study and/or device instructions.

23. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.

24. Subject suffers from life threatening conditions.

25. Subject currently participating in another clinical study.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Rex, Prof.

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Countries

United States

Other Identifiers

MA-203

Identifier Type: -

Identifier Source: org_study_id