Colorectal LesionsNCT01269372

Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

A study testing PillCam Colon 2 and Colonoscopy in people with Colorectal Lesions, run by Medtronic - MITG at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy. Read more about this study

Who is it for?: Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Colorectal Lesions
What is being tested?: PillCam Colon 2 and Colonoscopy
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Jul 2011
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 - 75 years of age, and an appropriate candidate for polyp screening.
Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Who cannot join

Subject has a history of colorectal cancer
Subjects with history of any positive colon assessment (including CT, colonoscopy, sigmoidoscopy etc.),
Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) < 5 years.
Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
Subject is suspected or diagnosed with familial adenomatous polyposis.
Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer.

Show all 25Show fewer

Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety
Subject is suspected or diagnosed with bowel obstruction.
Subject has dysphagia or any swallowing disorder.
Subject has congestive heart failure.
Subject has Diabetes.
Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months or other 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.
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 intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
Subject with strictures, fistulas and/or chronic constipation.
Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
Subject with known 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

1 site in 1 country.

United States1 site

Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320

Other trials in United States

About this study

This study will also use to evaluate the administrative feasibility and data management of study design.

Conditions: Colorectal Lesions
Being tested: PillCam Colon 2, Colonoscopy
Keywords: polyps, capsule endoscopy, colonoscopy
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 2Device
Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE).
Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.
ColonoscopyDevice
The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.

Study groups in NCT01269372
Study group	Role	What they receive
PillCam Colon 2 and Standard Colonoscopy	Other	All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy. Receives: Device: PillCam Colon 2; Device: Colonoscopy

What is being measured

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

Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity
PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.
Measured: Up to 6 weeks
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity
PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.
Measured: Up to 6 weeks

Secondary outcomes (2)

Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity
PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.
Measured: Up to 6 weeks
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity
PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.
Measured: Up to 6 weeks

Timeline

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

Dec 2010Jul 2011

First posted4 Jan 2011 (estimated)
Study startDec 2010
Primary completionJul 2011
Study completionJul 2011

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 LesionsStudies 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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01269372
Sponsor's protocol ID: MA-203
Status last verified: Jul 2020
First submitted: 18 Nov 2010
Last updated: 1 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
Recruiting
Screening Women With Prior HPV for Anal Neoplasia
HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias
Active, not recruitingObservational study
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Lung Non-Small Cell Carcinoma, Metastatic Colorectal Carcinoma

All Colorectal Lesions trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
ClinicalTrials.gov ID: NCT01269372
Acronym / sponsor ID: MA-203
Conditions: Colorectal Lesions
Keywords: polyps, capsule endoscopy, colonoscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Dec 2010 (actual)
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 4 Jan 2011 (estimated)
Results: Posted 1 Oct 2020

Clinical summary

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

This study will also use to evaluate the administrative feasibility and data management of study design.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind (care provider, investigator)
Number of arms: 1

Arm	Type	Receives
PillCam Colon 2 and Standard Colonoscopy	Other	Device: PillCam Colon 2, Device: ColonoscopyAll subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy.

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, and an appropriate candidate for polyp screening.
Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Key exclusion criteria (25 listed)

Subject has a history of colorectal cancer
Subjects with history of any positive colon assessment (including CT, colonoscopy, sigmoidoscopy etc.),
Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) < 5 years.
Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
Subject is suspected or diagnosed with familial adenomatous polyposis.

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 2Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.	Device	PillCam Colon 2 and Standard Colonoscopy
ColonoscopyThe colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.	Device	PillCam Colon 2 and Standard Colonoscopy

Primary outcome

Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity
Time frame: Up to 6 weeks
PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity
Time frame: Up to 6 weeks
PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

2 secondary outcomes

Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity
Time frame: Up to 6 weeks
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity
Time frame: Up to 6 weeks

Results and safety

Results posted to the registry on 1 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reporting Group	30	30

Primary outcome: Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity

Time frame: Up to 6 weeks. Number (95% Confidence Interval). Unit: percentage of sensitivity

Measure	PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp n = 30	PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp n = 30
Value	83 (42 to 99)	50 (9 to 91)

Population analysed: The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject.

Primary outcome: Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity

Time frame: Up to 6 weeks. Number (95% Confidence Interval). Unit: percentage of specificity

Measure	PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp n = 30	PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp n = 30
Value	92 (73 to 99)	100 (86 to 100)

Population analysed: The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PillCam Colon 2 and Standard Colonoscopy	0 of 30 (0%)	6 of 30 (20%)	0 of 30

Limitations and caveats (from the sponsor): This was a feasibility study, in accordance with the definition of a feasibility study within the ACT checklist. The feasibility study was used as preparation to study pivotal study number MA- 204 NCT01372878 which has results posted on CT.gov.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colorectal Lesions

RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
Recruiting
Screening Women With Prior HPV for Anal Neoplasia
HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias
Active, not recruitingObservational study
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Lung Non-Small Cell Carcinoma, Metastatic Colorectal Carcinoma

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

Indiana University

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

Questions about this trial

What is this clinical trial studying?

A study testing PillCam Colon 2 and Colonoscopy in people with Colorectal Lesions, run by Medtronic - MITG at 1 site 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 25 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 1 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 1 site 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 1 Oct 2020). 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 the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity (time frame: Up to 6 weeks). 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 NCT01269372.

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 1 Oct 2020.