Colonic DiseasesNCT01087528

Evaluation of PillCam™ Colon 2 in Visualization of the Colon

A study testing PillCam™ (Capsule Endoscopy) Colon 2 capsule in people with Colonic Diseases and Bowel Diseases, run by Medtronic - MITG at 4 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

To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Colonic Diseases, Bowel Diseases
What is being tested?: PillCam™ (Capsule Endoscopy) Colon 2 capsule
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 4 sitesUnited States
Study dates: Jul 2009to May 2010
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is between the ages of 18-70
Subject was referred to colonoscopy for at least one of the following reasons:
Colorectal cancer screening for age ≥60
Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits for age ≥50
Positive findings in the colon (e.g. Polyp ≥10mm)
Personal history of significant polyps( ≥6mm )that were removed at least 3 years ago (3 years and above)

Who cannot join

Age > 70 years
Subject has dysphagia or any swallowing disorder
Subject has congestive heart failure
Subject has known renal disease
Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator
Subject has any allergy or other known contraindication to the medications used in the study

Show all 17Show fewer

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 a cardiac pacemaker or other implanted electro medical device.
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, 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 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
Age>70

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Digestive Care, Inc.
Beavercreek, Ohio, 45440
University of North Carolina
Chapel Hill, North Carolina, 27599
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Indiana University Medical Center
Indianapolis, Indiana, 46202

Other trials in United States

About this study

To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.

Read the detailed description

Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by colonoscopy and radiology testing such as: air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy.

The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon. 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 . Furthermore, compared to standard colonoscopy, the Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.

The PillCam™ SB capsule (formerly M2A® Capsule) that was cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 1,000,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. To date, several clinical studies have been conducted with Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection.

Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.

This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.

Conditions: Colonic Diseases, Bowel Diseases
Being tested: PillCam™ (Capsule Endoscopy) Colon 2 capsule
Keywords: Colonic Diseases, bowel diseases, large bowel diseases
Medical subject headings: Colonic Diseases, Intestinal Diseases

What participants receive

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

PillCam™ (Capsule Endoscopy) Colon 2 capsuleDevice
Medical Device

Study groups in NCT01087528
Study group	Role	What they receive
1	Experimental	Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases. Receives: Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule

What is being measured

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

Accuracy of Detection in Patients With Colonic Polyps - Sensitivity
The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
Measured: within 7 days
Accuracy of Detection in Patients With Colonic Polyps - Specificity
The accuracy parameters (i.e. specificity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
Measured: within 7 days

Secondary outcomes (3)

Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions
The diagnostic yield (%) of PCCE-2 and colonoscopy in visualizing a variety of colonic lesion excluding polyps (e.g. inflammation, diverticulosis and bleeding lesions) is provided.
Measured: within 7 days
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent)
Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:
1. poor cleansing level (Large amount of fecal residue.)
2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)
3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)
4. excellent cleansing level (No more than small bits of adherent feces.)
Measured: within 7 days
Capsule Excretion Time
Capsule excretion time is defined as the duration of ingestion to capsule excretion time. The distribution of excretion times were categorized as follows:
- capsule excreted within 4 hours
- capsule excreted within 6 hours
- capsule excreted within 8 hours
- capsule excreted 8 hours and above
Measured: within 7 days

Timeline

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

Jul 2009May 2010

First posted16 Mar 2010 (estimated)
Study startJul 2009
Primary completionMay 2010
Study completionMay 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01087528
Sponsor's protocol ID: MA-202
Status last verified: Sep 2020
First submitted: 15 Mar 2010
Last updated: 22 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Morgan DR, Malik PR, Romeo DP, Rex DK. Initial US evaluation of second-generation capsule colonoscopy for detecting colon polyps. BMJ Open Gastroenterol. 2016 May 3;3(1):e000089. doi: 10.1136/bmjgast-2016-000089. eCollection 2016.
PubMed 27195129

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 Colonic Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of PillCam™ Colon 2 in Visualization of the Colon
ClinicalTrials.gov ID: NCT01087528
Acronym / sponsor ID: MA-202
Conditions: Colonic Diseases, Bowel Diseases
Keywords: Colonic Diseases, bowel diseases, large bowel diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Jul 2009 (actual)
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 16 Mar 2010 (estimated)
Results: Posted 8 Jun 2012

Clinical summary

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

To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.

Detailed description

Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Device: PillCam™ (Capsule Endoscopy) Colon 2 capsuleSubjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject is between the ages of 18-70
Subject was referred to colonoscopy for at least one of the following reasons:

Key exclusion criteria (17 listed)

Age > 70 years
Subject has dysphagia or any swallowing disorder
Subject has congestive heart failure
Subject has known renal disease
Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator

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™ (Capsule Endoscopy) Colon 2 capsuleMedical Device	Device	1

Primary outcome

Accuracy of Detection in Patients With Colonic Polyps - Sensitivity
Time frame: within 7 days
The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
Accuracy of Detection in Patients With Colonic Polyps - Specificity
Time frame: within 7 days
The accuracy parameters (i.e. specificity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.

3 secondary outcomes

Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions
Time frame: within 7 days
Percent of Participants With Scoring Index 3 or 4 (Good or Excellent)
Time frame: within 7 days
Capsule Excretion Time
Time frame: within 7 days

Results and safety

Results posted to the registry on 8 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colon Capsule Endoscopy, Then Standard Colonoscopy	51	44

Primary outcome: Accuracy of Detection in Patients With Colonic Polyps - Sensitivity

Time frame: within 7 days. Number (95% Confidence Interval). Unit: percentage of sensiivity

Measure	PillCam COLON n = 44
Patients with Polyp>= 6 mm	89 (61 to 98)
Patients with Polyp, >= 10 mm	100 (46 to 100)

Population analysed: Patients were included in the study due to a referral for colonoscopy for a variety of reasons such as recent change of bowel habits, prior positive findings, rectal bleeding, abdominal pain or a positive FOBT.

Primary outcome: Accuracy of Detection in Patients With Colonic Polyps - Specificity

Time frame: within 7 days. Number (95% Confidence Interval). Unit: percentage of specificity

Measure	PillCam COLON n = 44
Patients with Polyp>= 6 mm	43 (36 to 45)
Patients with Polyp, >= 10 mm	66 (62 to 66)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Colon Capsule Endoscopy, Then Standard Colonoscopy	0 of 51 (0%)	3 of 51 (5.9%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27195129Morgan DR, Malik PR, Romeo DP, Rex DK. Initial US evaluation of second-generation capsule colonoscopy for detecting colon polyps. BMJ Open Gastroenterol. 2016 May 3;3(1):e000089. doi: 10.1136/bmjgast-2016-000089. eCollection 2016.

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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, Dr. principal investigator

Division of Gastroenterology, Indiana University Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing PillCam™ (Capsule Endoscopy) Colon 2 capsule in people with Colonic Diseases and Bowel Diseases, run by Medtronic - MITG at 4 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 6 inclusion and 17 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 8 Jun 2012). 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?

Accuracy of Detection in Patients With Colonic Polyps - Sensitivity (time frame: within 7 days). The study lists 2 primary outcomes in all. 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 NCT01087528, which also lists 1 linked publication.

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 22 Oct 2020.