HealthyNCT00949208
Development of Applications of the Given® Diagnostic System and Evaluation of Their Performance
An observational study of Healthy, run by Medtronic - MITG at 2 sites in Israel.
Trial summary
The purpose of this study is to support the development of Given® Diagnostic System applications. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1,225 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2008to Aug 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria.
Who may be able to join
- Subject's age is between 18-75 years.
- Subject is healthy.
- Subject agrees to sign the Informed Consent Form.
Who cannot join
- Female subject is pregnant.
- Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
- Subject has a pacemaker or other implanted electro-medical device.
- Subject has undergone certain prior abdominal surgery of the gastrointestinal tract, (other than uncomplicated appendectomy or uncomplicated cholecystectomy) such as small bowel or colonic resection. This will be evaluated by the PI.
- Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
- Subject suffers from life threatening conditions.
- Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam - Medical center
Haifa, 31096
Given Imaging Ltd
Yoqneam, 20692
About this study
The purpose of this study is to support the development of Given® Diagnostic System applications.
Read the detailed description
This clinical study is designed to support the development of new generations of the Given® Diagnostic System and Agile™ Patency System that will accomplish better visualization, better diagnostic capabilities and will improve the system ease of use from the physician as well as patient's point of view.
*The PillCam™ Capsules Capsule endoscopy using the PillCam™ capsule (Given Imaging Limited, Yoqneam, Israel) represents the newest imaging modality of the gastrointestinal tract without the need for invasive techniques, sedation, or radiation exposure1-35. Initially cleared for marketing in August 2001 as an adjunctive modality, the FDA in 2003 cleared PillCam™ SB (previously called M2A) as a stand alone tool for detecting small bowel abnormalities in those patients who meet the device's indications.
The PillCam™ SB provides visualization of the entire small bowel mucosa and is presently purely a diagnostic test without therapeutic or biopsy potential.
Before capsule endoscopy, enteroscopy was one of the methods for examining the small bowel tract, but the diagnostic value of this test for a wide variety of specific lesions is low due to inability to reach the entire length of the small bowel.
Other endoscopic techniques include, Sonde enteroscopy, and intraoperative enteroscopy, but these are limited for several reasons including significant technical difficulties, length of procedures, potential risks, and frequently incomplete small bowel examination36-38. To date more than 400,000 PillCam™ SB capsules were ingested world wide. The Given® Diagnostic System (GDS) for Small Bowel is now the Gold standard.
Additional PillCam™ capsules were developed and are used for diagnosing the Esophagus as well as the Colon.
The PillCam™ ESO system received FDA clearance as well as the CE mark early 2005. To date, thousands of PillCam™ ESO capsules were ingested in both clinical trials and regular clinical setup worldwide with numerous published clinical studies39-45.
The PillCam™ COLON capsule received CE marking on October 15th, 2006 and is cleared for marketing in Europe. It is now pending FDA clearance. To date, several hundreds of PillCam™ COLON capsules were ingested in numerous pilot studies and ongoing multi-center studies in Europe and USA34-35.
*The Agile™ Patency System Small and large bowel strictures are present in a large spectrum of diseases and clinical situations such as adhesion related diseases, Crohn's disease, patients who are post abdominal radiation treatment and patients who have undergone abdominal surgery46. Knowledge of intestinal patency in such patients will aid the physician in assessment and treatment of the patients.
The current methods for identifying intestinal strictures primarily include small bowel follow through (SBFT), enteroclysis, computed tomography (CT) and enteroscopy but the diagnostic value of these tests is low. Advanced strictures are often missed and some of these methods include radiation and others are invasive.
The Agile™ Patency System is designed to aid the gastroenterologist in verifying the patency of the GI tract. The system is essentially based on small identification tags, which are detected by radio frequency (RFID) encapsulated in a disintegrating capsule. The RFID tags have been marketed for many years for veterinary use. In animals they are injected sub-dermally and are used for life-long identification, marking and tracking47.
Preliminary results demonstrate that the Agile System performs as intended48. Future developments of the unique technology which make up the Agile patency capsule will broaden its range of uses and applications beyond simple patency testing.
Agile ingestions are estimated in the excess of three thousand worldwide.
- Conditions
- Healthy
- Keywords
- Healthy people
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 | The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of new or modified features of the GDS presently under development
Measured: Within 7 Days
Capsule transition time throughout the all GI tract segments & Improved visualization of the mucosa and sub-mucosal structures (mostly by capsule modification)
Measured: Within 7 days
Improved automatic pathology identification & bowel cleanliness - index score
Measured: Within 7 days
Accuracy of capsule localization & Pathology size determination
Measured: Within 7 days
Secondary outcomes (1)
Identify and evaluate any additional features beneficial to GDS applications.
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 posted30 Jul 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 1,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yehuda Chowers, Prof., Principal investigator, Rambam Health Care CampusAri Bergwerk, Dr., Principal investigator, Given Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949208
- Sponsor's protocol ID
- RD-30
- Status last verified
- Mar 2016
- First submitted
- 29 Jul 2009
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Applications of the Given® Diagnostic System and Evaluation of Their Performance
- ClinicalTrials.gov ID
- NCT00949208
- Acronym / sponsor ID
- RD-30
- Conditions
- Healthy
- Keywords
- Healthy people
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,225 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Jul 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 support the development of Given® Diagnostic System applications.
Detailed description
This clinical study is designed to support the development of new generations of the Given® Diagnostic System and Agile™ Patency System that will accomplish better visualization, better diagnostic capabilities and will improve the system ease of use from the physician as well as patient's point of view.
*The PillCam™ Capsules Capsule endoscopy using the PillCam™ capsule (Given Imaging Limited, Yoqneam, Israel) represents the newest imaging modality of the gastrointestinal tract without the need for invasive techniques, sedation, or radiation exposure1-35. Initially cleared for marketing in August 2001 as an adjunctive modality, the FDA in 2003 cleared PillCam™ SB (previously called M2A) as a stand alone tool for detecting small bowel abnormalities in those patients who meet the device's indications.
The PillCam™ SB provides visualization of the entire small bowel mucosa and is presently purely a diagnostic test without therapeutic or biopsy potential.
Before capsule endoscopy, enteroscopy was one of the methods for examining the small bowel tract, but the diagnostic value of this test for a wide variety of specific lesions is low due to inability to reach the entire length of the small bowel.
Other endoscopic techniques include, Sonde enteroscopy, and intraoperative enteroscopy, but these are limited for several reasons including significant technical difficulties, length of procedures, potential risks, and frequently incomplete small bowel examination36-38. To date more than 400,000 PillCam™ SB capsules were ingested world wide. The Given® Diagnostic System (GDS) for Small Bowel is now the Gold standard.
Additional PillCam™ capsules were developed and are used for diagnosing the Esophagus as well as the Colon.
The PillCam™ ESO system received FDA clearance as well as the CE mark early 2005. To date, thousands of PillCam™ ESO capsules were ingested in both clinical trials and regular clinical setup worldwide with numerous published clinical studies39-45.
The PillCam™ COLON capsule received CE marking on October 15th, 2006 and is cleared for marketing in Europe. It is now pending FDA clearance. To date, several hundreds of PillCam™ COLON capsules were ingested in numerous pilot studies and ongoing multi-center studies in Europe and USA34-35.
*The Agile™ Patency System Small and large bowel strictures are present in a large spectrum of diseases and clinical situations such as adhesion related diseases, Crohn's disease, patients who are post abdominal radiation treatment and patients who have undergone abdominal surgery46. Knowledge of intestinal patency in such patients will aid the physician in assessment and treatment of the patients.
The current methods for identifying intestinal strictures primarily include small bowel follow through (SBFT), enteroclysis, computed tomography (CT) and enteroscopy but the diagnostic value of these tests is low. Advanced strictures are often missed and some of these methods include radiation and others are invasive.
The Agile™ Patency System is designed to aid the gastroenterologist in verifying the patency of the GI tract. The system is essentially based on small identification tags, which are detected by radio frequency (RFID) encapsulated in a disintegrating capsule. The RFID tags have been marketed for many years for veterinary use. In animals they are injected sub-dermally and are used for life-long identification, marking and tracking47.
Preliminary results demonstrate that the Agile System performs as intended48. Future developments of the unique technology which make up the Agile patency capsule will broaden its range of uses and applications beyond simple patency testing.
Agile ingestions are estimated in the excess of three thousand worldwide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria.
Key inclusion criteria (3 listed)
- Subject's age is between 18-75 years.
- Subject is healthy.
- Subject agrees to sign the Informed Consent Form.
Key exclusion criteria (7 listed)
- Female subject is pregnant.
- Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
- Subject has a pacemaker or other implanted electro-medical device.
- Subject has undergone certain prior abdominal surgery of the gastrointestinal tract, (other than uncomplicated appendectomy or uncomplicated cholecystectomy) such as small bowel or colonic resection. This will be evaluated by the PI.
- Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
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
Assessment of new or modified features of the GDS presently under development
Time frame: Within 7 Days
Capsule transition time throughout the all GI tract segments & Improved visualization of the mucosa and sub-mucosal structures (mostly by capsule modification)
Time frame: Within 7 days
Improved automatic pathology identification & bowel cleanliness - index score
Time frame: Within 7 days
Accuracy of capsule localization & Pathology size determination
Time frame: Within 7 days
1 secondary outcome
Identify and evaluate any additional features beneficial to GDS applications.
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 5 Aug 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.
Yehuda Chowers, Prof. principal investigator
Rambam Health Care Campus
Ari Bergwerk, Dr. principal investigator
Given Imaging
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Medtronic - MITG at 2 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 3 inclusion and 7 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Assessment of new or modified features of the GDS presently under development (time frame: Within 7 Days). The study lists 4 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 5 Aug 2016.