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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Drug: Erythromycin; Drug: Metoclopramide; Drug: Bisacodyl; Device: PillCam® COLON 2 procedure-CONTROL; Drug: Senna tablets; Drug: PEG; Drug: SUPREP oral sulfate solution; Drug: SUPREP oral sulfate solution with Gastrografin

Detailed 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 adverse events.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital
    • Indianapolis, Indiana, United States, 46237
      • Indianapolis Gastroenterology and Hepatology
  • Ohio
    • Dayton, Ohio, United States, 45440
      • Dayton Gastroenterology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Gastroenterology, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 colorectal cancer (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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bowel preparation regimen -Control; Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.	Drug: Erythromycin; Drug: Metoclopramide; Drug: Bisacodyl; Device: PillCam® COLON 2 procedure-CONTROL; Drug: Senna tablets; Drug: PEG; Drug: SUPREP oral sulfate solution
Experimental: Bowel preparation regimen-Test; Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.	Drug: Erythromycin; Drug: Metoclopramide; Drug: Bisacodyl; Device: PillCam® COLON 2 procedure-CONTROL; Drug: Senna tablets; Drug: PEG; Drug: SUPREP oral sulfate solution with Gastrografin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (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).	Within two weeks of study procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE	Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment	an expected average of 3 weeks from study procedure
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
Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE	Will be assesses by applicable case report form (CRF)	an expected average of 3 weeks from study procedure
Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE	Will be assesses by applicable CRF	Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Douglas K Rex, Dr.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: January 22, 2017
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Capsule endoscopy; Polyps; Bowel preparation regimen; Average risk patients for colorectal cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antiemetics; Gastrointestinal Agents; Anti-Bacterial Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Protein Synthesis Inhibitors; Cathartics; Laxatives; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Pharmaceutical Solutions; Bisacodyl; Metoclopramide
• Other Study ID Numbers: MA-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No