Colorectal Cancer ScreeningNCT02481219

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

A study testing Senna tablets, PEG and Metoclopramide in people with Colorectal Cancer Screening, run by Medtronic - MITG at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer Screening
What is being tested?: Senna tablets, PEG and Metoclopramide
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 6 sitesUnited States
Study dates: May 2015to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Colorectal Cancer Screening
Being tested: PillCam® COLON 2 procedure-CONTROL, Senna tablets, PEG, Metoclopramide, Erythromycin
Keywords: Polyps, Capsule endoscopy, Bowel preparation regimen, Average risk patients for colorectal cancer screening
Medical subject headings: Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PillCam® COLON 2 procedure-CONTROLDevice
Senna tabletsDrug
PEGDrug
MetoclopramideDrug
ErythromycinDrug
SUPREP oral sulfate solutionDrug
BisacodylDrug
SUPREP oral sulfate solution with GastrografinDrug

Study groups in NCT02481219
Study group	Role	What they receive
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. Receives: 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. Receives: Device: PillCam® COLON 2 procedure-CONTROL; Drug: Senna tablets; Drug: PEG; Drug: Metoclopramide; Drug: Erythromycin; Drug: Bisacodyl; Drug: SUPREP oral sulfate solution with Gastrografin

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Within two weeks of study procedure

Secondary outcomes (5)

Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Will be assessed from RAPID video in total and by segment
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Feb 2016

First posted25 Jun 2015 (estimated)
Study startMay 2015
Primary completionJan 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02481219
Sponsor's protocol ID: MA-205
Status last verified: Jun 2015
First submitted: 19 May 2015
Last updated: 7 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer Screening trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure
ClinicalTrials.gov ID: NCT02481219
Acronym / sponsor ID: MA-205
Conditions: Colorectal Cancer Screening
Keywords: Polyps, Capsule endoscopy, Bowel preparation regimen, Average risk patients for colorectal cancer screening
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Jan 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 25 Jun 2015 (estimated)
Results: Posted 11 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bowel preparation regimen -Control	Active comparator	Device: PillCam® COLON 2 procedure-CONTROL, Drug: Senna tablets, Drug: PEG, Drug: Metoclopramide, Drug: Erythromycin, Drug: SUPREP oral sulfate solution, Drug: BisacodylRegimen 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.
Bowel preparation regimen-Test	Experimental	Device: PillCam® COLON 2 procedure-CONTROL, Drug: Senna tablets, Drug: PEG, Drug: Metoclopramide, Drug: Erythromycin, Drug: Bisacodyl, Drug: SUPREP oral sulfate solution with GastrografinRegimen 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.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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

Primary outcome

Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Time frame: Within two weeks of study procedure
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).

5 secondary outcomes

Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Time frame: an expected average of 3 weeks from study procedure
Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE
Time frame: an expected average of 3 weeks from study procedure
Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE
Time frame: 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
Time frame: an expected average of 3 weeks from study procedure
Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE
Time frame: Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.

Results and safety

Results posted to the registry on 11 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bowel Preparation Regimen -Control	60	58
Bowel Preparation Regimen-Test	62	61

Primary outcome: Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)

Time frame: Within two weeks of study procedure. Number. Unit: percentage of particpants

Measure	Bowel Preparation Regimen -Control n = 44	Bowel Preparation Regimen-Test n = 54
Overall Excellent cleansing	6.8	16.7
Cecum Excellent cleansing	14.0	14.6
Ascending Excellent cleansing	12.2	18.2
Transverse Excellent cleansing	10.6	14.6
Descending Excellent cleansing	9.5	18.5
Rectum Excellent cleansing	0	10.0
Overall Good cleansing	70.5	59.3
Cecum Good cleansing	54.0	52.7

Population analysed: this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bowel Preparation Regimen -Control	0 of 59 (0%)	2 of 59 (3.4%)	Not reported
Bowel Preparation Regimen-Test	1 of 62 (1.6%)	12 of 62 (19.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas K Rex, Dr. principal investigator

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Senna tablets, PEG and Metoclopramide in people with Colorectal Cancer Screening, run by Medtronic - MITG at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) (time frame: Within two weeks of study procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02481219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.