Colonic DiseasesNCT00440791
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
An observational study of Colonic Diseases, run by Medtronic - MITG at 7 sites in 2 countries.
Trial summary
This multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- PillCam Colon capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 40 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2006to Jul 2007
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:
- Subject was referred for standard colonoscopy for one of the following reasons:
- Subjects over 50 years of age with one or more of the following clinical symptoms:
- rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits
- Any subject over 18 years of age with:
- Positive findings in the colon on a GI radiographic study (e.g., CT colonography, air-contrast barium enema, abdominal/pelvic CT scan)
- Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 5 years since last colonoscopy or no sooner than 3 years prior to enrollment date as long as their prior colonoscopy revealed at least one of the following high risk conditions: multiple (greater than 3)adenomas, large adenoma (greater than 1 cm) , adenomas with a villous component, adenoma with high grade dysplasia.
- Suspected or known ulcerative colitis
Who cannot join
- The presence of any of the following will exclude a subject from study enrollment:
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Subject has a cardiac pacemaker or other implanted electro medical devices.
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- Subject is pregnant
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Indiana University Hospital
Indianapolis, Indiana, 46202
Minnesota Gastroenterology
Minneapolis, Minnesota, 55446
Private Medical Facility
New York, New York, 10128
Oregon Health Sciences University
Portland, Oregon, 97239-3098
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
This multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)
Read the detailed description
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . This multi-center prospective, cohort study will evaluate the performance of PCCE in visualizing the colon. Up to 394 subjects will participate in this study. All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication.
Each subject will undergo PCCE. All generated PCCE RAPID videos will be reviewed by blinded PCCE reading physicians. All readers, experienced in PillCam SB, will have undergone standardized training and passed a qualification test specific to reading and interpreting PCCE videos. Training will be done by reading at least 5 cases to demonstrate proficiency in interpretation of PCCE. PCCE results will be compared with that of a colonoscopy procedure.
Following PCCE procedure, standard colonoscopy will be performed by a colonoscopist blinded to the results of the PCCE. The colonoscopist will be "unblinded" during the standard colonoscopy procedure at three locations on withdrawal of the colonoscope.
Primary Endpoint - Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy.
- Number, type and severity of adverse events with both PCCE and standard colonoscopy
- Conditions
- Colonic Diseases
- Being tested
- PillCam Colon capsule endoscopy
- Keywords
- Colon, colonic disease, capsule endoscopy, Suspected or known colonic disease
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam Colon capsule endoscopyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startJun 2006
- Study completionJul 2007
Why it stopped: Interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Douglas Rex, M.D., Principal investigator, Indiana University HospitalGlenn Eisen, M.D., Principal investigator, Oregon Health and Science UniversityRami Eliakim, MD, Principal investigator, Rambam Health Care CampusJonathan Leighton, MD, Principal investigator, Mayo ClinicChris Gostout, MD, Principal investigator, Mayo ClinicElizabeth Rajan, MD, Principal investigator, Mayo ClinicBlair Lewis, MD, Principal investigator, Private Medical FacilityS Ketover, MD, Principal investigator, Minnesota Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440791
- Sponsor's protocol ID
- MA-54
- Status last verified
- Aug 2007
- First submitted
- 26 Feb 2007
- 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 the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
- ClinicalTrials.gov ID
- NCT00440791
- Acronym / sponsor ID
- MA-54
- Conditions
- Colonic Diseases
- Keywords
- Colon, colonic disease, capsule endoscopy, Suspected or known colonic disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim analysis
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 27 Feb 2007 (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.
This multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)
Detailed description
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . This multi-center prospective, cohort study will evaluate the performance of PCCE in visualizing the colon. Up to 394 subjects will participate in this study. All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication.
Each subject will undergo PCCE. All generated PCCE RAPID videos will be reviewed by blinded PCCE reading physicians. All readers, experienced in PillCam SB, will have undergone standardized training and passed a qualification test specific to reading and interpreting PCCE videos. Training will be done by reading at least 5 cases to demonstrate proficiency in interpretation of PCCE. PCCE results will be compared with that of a colonoscopy procedure.
Following PCCE procedure, standard colonoscopy will be performed by a colonoscopist blinded to the results of the PCCE. The colonoscopist will be "unblinded" during the standard colonoscopy procedure at three locations on withdrawal of the colonoscope.
Primary Endpoint - Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy.
- Number, type and severity of adverse events with both PCCE and standard colonoscopy
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:
- rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits
- Any subject over 18 years of age with:
- Positive findings in the colon on a GI radiographic study (e.g., CT colonography, air-contrast barium enema, abdominal/pelvic CT scan)
- Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 5 years since last colonoscopy or no sooner than 3 years prior to enrollment date as long as their prior colonoscopy revealed at least one of the following high risk conditions: multiple (greater than 3)adenomas, large adenoma (greater than 1 cm) , adenomas with a villous component, adenoma with high grade dysplasia.
Key exclusion criteria (11 listed)
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Subject has a cardiac pacemaker or other implanted electro medical devices.
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 capsule endoscopy | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Interim analysis). Results are not available in the source record.
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, M.D. principal investigator
Indiana University Hospital
Glenn Eisen, M.D. principal investigator
Oregon Health and Science University
Rami Eliakim, MD principal investigator
Rambam Health Care Campus
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Diseases, run by Medtronic - MITG at 7 sites in 2 countries.
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 8 inclusion and 11 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: stopped early, 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, Israel. 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?
The study was stopped early (reason given: Interim analysis). Results are not available in the source record.
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.
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.