Optimization of the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

Colorectal Cancer Screening Clinical Trial

Official title:

MA-205 / COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02481219
• Other study ID #: MA-205
• 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

• Colorectal Cancer Screening
• Colorectal Neoplasms

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