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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02481219
Other study ID # MA-205
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 19, 2015
Last updated December 3, 2015
Start date May 2015
Est. completion date February 2016

Study information

Verified date June 2015
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.

Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.


Description:

This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE.

Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any AEs.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

1. Subject is between 50 and 75 years of age.

2. Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.

3. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.

Exclusion Criteria:

1. Subject with history of polyps (including those identified by computed tomography [CT], optical colonoscopy, sigmoidoscopy, etc.).

2. Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) within 5 years as these subjects would be defined not requiring screening in this time frame.

3. Subject with suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.

4. Subject with any condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.

5. Subject with dysphagia or any swallowing disorder.

6. Subject with serious medical conditions that would increase the risk associated with capsule or colonoscopy that are so severe that screening would have no benefit.

7. Subject with a cardiac pacemaker or other implanted electromedical device.

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

9. Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local laboratory reference range.

10. Subject with known gastrointestinal motility disorders.

11. Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.

12. Subject with comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.

13. Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).

14. Subject is pregnant, suspected pregnant, or is actively breast-feeding. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years).

15. Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
PillCam® COLON 2 procedure-CONT

Drug:
Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

SUPREP oral sulfate solution with Gastrografin


Locations

Country Name City State
United States Pinnacle Research Group, LLC Anniston Alabama
United States Dayton Gastroenterology Dayton Ohio
United States Franklin Gastroenterology, PLLC Franklin Tennessee
United States Indianapolis Gastroenterology and Hepatology Indianapolis Indiana
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparing bowel cleansing level of two different bowel preparation methods for PillCam CCE The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum). an expected 3 weeks from study procedure Yes
Secondary Comparing polyp detection rate of two different bowel preparation methods for PillCam CCE Will be assessed from RAPID video in total and by segment an expected average of 3 weeks from study procedure No
Secondary Comparing of Colonic transit time of two different bowel preparation methods for PillCam CCE Will be assessed from RAPID video in total and by segment an expected average of 3 weeks from study procedure No
Secondary Comparing of completion rate of capsule of two different bowel preparation methods for PillCam CCE Will be assessed from RAPID video in total and by segment an expected average of 3 weeks from study procedure No
Secondary Comparing of excretion rate of capsule within 12 hours of two different bowel preparation methods for PillCam CCE Will be assesses by applicable CRF an expected average of 3 weeks from study procedure No
Secondary Comparing adverse events rate between two different bowel preparation methods for PillCam CCE Will be assesses by applicable CRF an expected average of 3 weeks from study procedure Yes
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