Bowel DiseasesNCT00884624
Evaluation of the PillCam™ Colon Capsule -2 System
An observational study of Bowel Diseases, run by Medtronic - MITG at 5 sites in Israel.
Trial summary
The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon. Read more about this study
- Who is it for?
- Ages 18 to 57 years
- Conditions the study is for
- Bowel Diseases
- How many people
- 255 participants
- Where
- 5 sitesIsrael
- Study dates
- Mar 2009to Mar 2010
- 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 to 57 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
Who may be able to join
- Subject is between the ages of 18-57 years.
- Subject is able and agrees to sign the Informed Consent Form
- Subject was referred to colonoscopy for at least one of the following reasons:
- Colorectal cancer screening
- Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.
- Positive findings in the colon on a GI radiographic study
Show all 9Show fewer
- Personal history of colorectal cancer (CRC) or adenomatous polyps and at least 5 years since last conventional colonoscopy
- Positive findings in the colon
- Personal history of polyps that were removed at least 5 years ago (5 years and more)
Who cannot join
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject has Nephrotic syndrome
- Subject has Cirrhosis
- Subject is known or is suspected to suffer from intestinal obstruction.
Show all 20Show fewer
- Subject is taking NSAID medication
- Subject suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers
- Chronic use of laxatives
- Subject has a cardiac pacemakers or other implanted electro medical devices.
- Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- 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 < 18 years or under parent guardian
- Age>57 years
- Subject suffers from life threatening conditions
- Subject is currently participating in another clinical study
- Subject has known slow gastric emptying time
- Subject is allergic or contraindicated to any of the study medications
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Hillel Yaffe Hospital
Hadera, 38101
Rambam - Medical center
Haifa, 31096
Bikkur Holim Hospital
Jerusalem
Meir Medical Center
Kfar Saba, 95347
Rabin Medical Center
Petah Tikva, 49100
About this study
The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon.
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 500,000 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 PillCam™ Colon Endoscope 1(PCCE-1) system. The new development of PillCam Colon Endoscope 2 (PCCE-2) is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the PillCam™ Colon Capsule Endoscope (PCCE-2) can be found in the device description section.
This study is designed to evaluate the performance of the new version of colon capsule and its performance in detecting lesions in the colon as compared to conventional colonoscopy.
- Conditions
- Bowel Diseases
- Keywords
- Bowel Diseases
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy parameters of PCCE-2 in detecting colonic polyps as compared to conventional colonoscopy
Measured: Within 7 Days
Assessment of colon cleansing level at different colon segments
Measured: Within 7 days
Distribution of capsule excretion time
Measured: Within 7 Days
Percent of excreted capsules up to 10 hours post capsule ingestion.
Measured: Within 7 Days
Number, type and severity of adverse events
Measured: WithIn 7 days
Secondary outcomes (8)
Accuracy parameters of PCCE-2 in detecting colonic lesions as compared to conventional colonoscopy
Measured: within 7 days
Capsule transit time within stomach, small bowel and colon
Measured: within 7 days
Number of polyps and sizes at different colon segments detected by capsule
Measured: within 7 days
Number of polyps and sizes at different colon segments detected by conventional colonoscopy
Measured: within 7 days
RAPID video reading time
Measured: Within 7 days
Conventional colonoscopy duration including: total time, insertion time, and withdrawal time see my comment above (at the objective section)
Measured: Within 7 Days
Assessment of the RAPID video
Measured: Within 7 Days
Patient questionnaire
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.
- First posted21 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rami Eliakim, Prof., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884624
- Sponsor's protocol ID
- MA-200
- Status last verified
- Mar 2010
- First submitted
- 20 Apr 2009
- 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 -2 System
- ClinicalTrials.gov ID
- NCT00884624
- Acronym / sponsor ID
- MA-200
- Conditions
- Bowel Diseases
- Keywords
- Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Apr 2009 (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 this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon.
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 500,000 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 PillCam™ Colon Endoscope 1(PCCE-1) system. The new development of PillCam Colon Endoscope 2 (PCCE-2) is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the PillCam™ Colon Capsule Endoscope (PCCE-2) can be found in the device description section.
This study is designed to evaluate the performance of the new version of colon capsule and its performance in detecting lesions in the colon as compared to conventional colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases. |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
Key inclusion criteria (9 listed)
- Subject is between the ages of 18-57 years.
- Subject is able and agrees to sign the Informed Consent Form
- Subject was referred to colonoscopy for at least one of the following reasons:
Key exclusion criteria (20 listed)
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject has Nephrotic syndrome
- Subject has Cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy parameters of PCCE-2 in detecting colonic polyps as compared to conventional colonoscopy
Time frame: Within 7 Days
Assessment of colon cleansing level at different colon segments
Time frame: Within 7 days
Distribution of capsule excretion time
Time frame: Within 7 Days
Percent of excreted capsules up to 10 hours post capsule ingestion.
Time frame: Within 7 Days
Number, type and severity of adverse events
Time frame: WithIn 7 days
8 secondary outcomes
Accuracy parameters of PCCE-2 in detecting colonic lesions as compared to conventional colonoscopy
Time frame: within 7 days
Capsule transit time within stomach, small bowel and colon
Time frame: within 7 days
Number of polyps and sizes at different colon segments detected by capsule
Time frame: within 7 days
Number of polyps and sizes at different colon segments detected by conventional colonoscopy
Time frame: within 7 days
RAPID video reading time
Time frame: Within 7 days
Conventional colonoscopy duration including: total time, insertion time, and withdrawal time see my comment above (at the objective section)
Time frame: Within 7 Days
Assessment of the RAPID video
Time frame: Within 7 Days
Patient questionnaire
Time frame: Within 7 days
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.
Rami Eliakim, Prof. principal investigator
Rambam Health Care Campus
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Diseases, run by Medtronic - MITG at 5 sites in Israel.
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 9 inclusion and 20 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 5 sites in 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 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?
Accuracy parameters of PCCE-2 in detecting colonic polyps as compared to conventional colonoscopy (time frame: Within 7 Days). The study lists 5 primary outcomes in all. 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.