ColonoscopyPhase 2/3NCT01185002
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
A Phase 2/3 study testing PillCam® COLON 2 procedure using MgC boosts, PillCam® COLON 2 procedure using Suprep boosts and PillCam® COLON 2 procedure using reduced dose of Suprep boosts in people with Colonoscopy and Endoscopy, run by Medtronic - MITG at 7 sites in United States.
Trial summary
The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Endoscopy
- What is being tested?
- PillCam® COLON 2 procedure using MgC boosts, PillCam® COLON 2 procedure using Suprep boosts and PillCam® COLON 2 procedure using reduced dose of Suprep boosts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2010to Jun 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 - 75 years of age.
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
Who cannot join
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Subject has Diabetes type I.
- Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
- Subject has a cardiac pacemaker or other implanted electro medical device.
- Subject has any allergy or other known contraindication to the medications used in the study
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- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
- Subject with gastrointestinal motility disorders
- Subject has known delayed gastric emptying
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Digestive Care, Inc.
Beavercreek, Ohio, 45440
University of North Carolina Division of Digestive Disease
Chapel Hill, North Carolina, 27599
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Franklin Gastroenterology
Franklin, Tennessee, 37067
Alabama Digestive Disorders Center
Huntsville, Alabama, 35802
Division of Gastroenterology Indiana University Medical Center
Indianapolis, Indiana, 46202
Research Associates of New York
New York, New York, 10075
About this study
The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.
Read the detailed description
Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).
- Conditions
- Colonoscopy, Endoscopy
- Being tested
- PillCam® COLON 2 procedure using MgC boosts, PillCam® COLON 2 procedure using Suprep boosts, PillCam® COLON 2 procedure using reduced dose of Suprep boosts
- Keywords
- CE, colonoscopy, colon, Eligable for colon evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam® COLON 2 procedure using MgC boostsOther
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.
PillCam® COLON 2 procedure using Suprep boostsOther
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts
PillCam® COLON 2 procedure using reduced dose of Suprep boostsOther
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts
| Study group | Role | What they receive |
|---|---|---|
| MgC boosts | Experimental | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects will be administered MgC boosts. Receives: Other: PillCam® COLON 2 procedure using MgC boosts |
| Suprep boosts | Experimental | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects will be administered Suprep boosts Receives: Other: PillCam® COLON 2 procedure using Suprep boosts |
| Suprep boosts - Reduced dose | Experimental | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects will be administered a reduced dose of Suprep boosts Receives: Other: PillCam® COLON 2 procedure using reduced dose of Suprep boosts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsule excretion rate
Measured: 10 hours post capsule ingestion
Secondary outcomes (1)
Distribution of PillCam® COLON 2 excretion times
Measured: Up to 12 hours and at least 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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 2/3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Rex, Prof., Principal investigator, Division of Gastroenterology Indiana University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185002
- Sponsor's protocol ID
- MA-111
- Status last verified
- Feb 2011
- First submitted
- 18 Aug 2010
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
- ClinicalTrials.gov ID
- NCT01185002
- Acronym / sponsor ID
- MA-111
- Conditions
- Colonoscopy, Endoscopy
- Keywords
- CE, colonoscopy, colon, Eligable for colon evaluation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.
Detailed description
Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MgC boosts | Experimental | Other: PillCam® COLON 2 procedure using MgC boostsSubjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered MgC boosts. |
| Suprep boosts | Experimental | Other: PillCam® COLON 2 procedure using Suprep boostsSubjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered Suprep boosts |
| Suprep boosts - Reduced dose | Experimental | Other: PillCam® COLON 2 procedure using reduced dose of Suprep boostsSubjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered a reduced dose of Suprep boosts |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is between 50 - 75 years of age.
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
Key exclusion criteria (14 listed)
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Subject has Diabetes type I.
- Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
- Subject has a cardiac pacemaker or other implanted electro medical device.
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 using MgC boostsSubjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts. | Other | MgC boosts |
| PillCam® COLON 2 procedure using Suprep boostsSubjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts | Other | Suprep boosts |
| PillCam® COLON 2 procedure using reduced dose of Suprep boostsSubjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts | Other | Suprep boosts - Reduced dose |
Primary outcome
Capsule excretion rate
Time frame: 10 hours post capsule ingestion
1 secondary outcome
Distribution of PillCam® COLON 2 excretion times
Time frame: Up to 12 hours and at least 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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 Rex, Prof. principal investigator
Division of Gastroenterology Indiana University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PillCam® COLON 2 procedure using MgC boosts, PillCam® COLON 2 procedure using Suprep boosts and PillCam® COLON 2 procedure using reduced dose of Suprep boosts in people with Colonoscopy and Endoscopy, run by Medtronic - MITG at 7 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 2 inclusion and 14 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Capsule excretion rate (time frame: 10 hours post capsule ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2019.