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

NCT02481219 | Completed Results

• 1 other identifier: MA-205
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Colorectal Cancer Screening

Keywords

Polyps; Capsule endoscopy; Bowel preparation regimen; Average risk patients for colorectal cancer screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE

  an expected average of 3 weeks from study procedure

• Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE

  an expected average of 3 weeks from study procedure

• Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE

  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

  an expected average of 3 weeks from study procedure

• Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE

  Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.

Study Arms (2)

Bowel preparation regimen -Control

ACTIVE COMPARATOR

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.

Device: PillCam® COLON 2 procedure-CONTROL; Drug: Senna tablets; Drug: PEG; Drug: Metoclopramide; Drug: Erythromycin; Drug: SUPREP oral sulfate solution; Drug: Bisacodyl

Bowel preparation regimen-Test

EXPERIMENTAL

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.

Device: PillCam® COLON 2 procedure-CONTROL; Drug: Senna tablets; Drug: PEG; Drug: Metoclopramide; Drug: Erythromycin; Drug: Bisacodyl; Drug: SUPREP oral sulfate solution with Gastrografin

Interventions

PillCam® COLON 2 procedure-CONTROL DEVICE

Bowel preparation regimen -Control; Bowel preparation regimen-Test

Senna tablets DRUG

Bowel preparation regimen -Control; Bowel preparation regimen-Test

PEG DRUG

Bowel preparation regimen -Control; Bowel preparation regimen-Test

Metoclopramide DRUG

Bowel preparation regimen -Control; Bowel preparation regimen-Test

Erythromycin DRUG

Bowel preparation regimen -Control; Bowel preparation regimen-Test

SUPREP oral sulfate solution DRUG

Bowel preparation regimen -Control

Bisacodyl DRUG

Bowel preparation regimen -Control; Bowel preparation regimen-Test

SUPREP oral sulfate solution with Gastrografin DRUG

Bowel preparation regimen-Test

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 and 75 years of age.
• 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.
• Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.

You may not qualify if:

• Subject with history of polyps (including those identified by computed tomography \[CT\], optical colonoscopy, sigmoidoscopy, etc.).
• 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.
• 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.
• Subject with any condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
• Subject with dysphagia or any swallowing disorder.
• 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.
• Subject with a cardiac pacemaker or other implanted electromedical device.
• Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.
• 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.
• Subject with known gastrointestinal motility disorders.
• Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.
• 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.
• Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
• 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).
• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (6)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Indianapolis Gastroenterology and Hepatology

Indianapolis, Indiana, 46237, United States

Location

Dayton Gastroenterology

Dayton, Ohio, 45440, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Franklin Gastroenterology, PLLC

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Polyps

Interventions

Sennosides; Metoclopramide; Erythromycin; Bisacodyl; Diatrizoate Meglumine

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Phenyl Ethers; Phenols; Macrolides; Polyketides; Lactones; Cresols; Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Diatrizoate; Triiodobenzoic Acids; Iodobenzoates; Hexosamines; Amino Sugars

Results Point of Contact

• Title: Liron Bar Yaakov
• Organization: Given Imaging (a Medtronic company)

liron.bar-yaakov@covidien.com

+97249097946

Study Officials

• Douglas K Rex, Dr.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: June 25, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 7, 2017
• Results First Posted: July 11, 2016

Record last verified: 2015-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)