Intestinal AbnormalitiesNCT01085513
Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy
A study testing PillCam SB2 in people with Intestinal Abnormalities, run by Medtronic - MITG at 6 sites in 5 countries.
Trial summary
Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and… Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Abnormalities
- What is being tested?
- PillCam SB2
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Feb 2009to Jun 2013
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient's age is 16-80 years, inclusive.
- One of the following SB manometry procedures:
- Underwent SB manometry within five years if results were abnormal
- Underwent SB manometry within 1 year if results were normal
- Scheduled for SB manometry within six months of enrollment date
- Patient was indicated for small bowel manometry based on one or both of the following symptoms:
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- Pseudo obstruction of the small bowel: symptoms resembling mechanical small bowel obstruction without evidence of luminal compromise of the gut. Mechanical occlusion is ruled-out by endoscopic and / or radiological studies following the criteria of the attending physician.
- Patients may have any of the following:
- recurrent acute episodes (at least two) with air fluid levels (as evidenced at least once by abdominal X-ray), or
- chronic symptoms with small bowel dilation resembling a partial mechanical obstruction.
- Patients will be tested during period of (non-acute) remission. - Chronic severe GI symptoms with inability to maintain normal body weight: abdominal symptoms (such as nausea, abdominal distension, discomfort or pain) produce inability to maintain a normal body weight as defined by unintentional weight loss of at least 10% of original body weight before onset of symptoms or a BMI < 18.5, while on a normal diet (without oral dietary supplements, enteral or parenteral feeding).
- These should be chronic symptoms lasting at least 6 months.
- Patient or legal guardian agrees to sign consent form
- Volunteer's age is 16-80 years, inclusive.
- Volunteer or legal guardian agrees to sign consent form. 6.5.2 Exclusion criteria - Healthy Volunteers
- Known diabetes mellitus
- Recurrent Gastrointestinal symptoms
- Volunteer suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions
- Non-steroidal anti-inflammatory drugs including aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
- More than one answer above 'mild' on the healthy volunteer symptoms questionnaire (Appendix C).
- Female volunteer is pregnant
- Known abuse of alcohol or illicit substances.
- Participating in another clinical study within 30 days
Who cannot join
- Acute exacerbation of chronic obstructive symptoms.
- Mechanical obstruction of any kind such as definite long stricture seen on radiological exam.
- Suspected GI stricture, followed by Agile® study that could not prove patency of the GI tract.
- Known history of small bowel organic disease such as Crohn's Disease or Celiac.
- Patient suffers from any condition, such as swallowing problems or having an implanted cardiac pacemaker or defibrillator which precludes compliance with study and/or device instructions.
- Non-steroidal anti-inflammatory drugs including aspirin, (twice weekly or more) during the 4 weeks preceding the CE exam.
Show all 13Show fewer
- Patient has undergone gastrectomy (segmental small bowel resection over 30%).
- During the period between small bowel manometry and Capsule endoscopy, the patient has undergone any abdominal surgical procedures other than appendectomy, cholecystectomy, abdominal wall hernia repair or catheter placing for enteral feeding.
- Manometry was performed before any other allowed GI procedure.
- Patient is pregnant.
- Known abuse of alcohol or illicit substances.
- Patient presently presenting with an acute life threatening condition.
- Participating in another clinical study within 30 days.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
Mayo Clinic,
Rochester, Minnesota, 55905
Division of Gastroenterology and Hepatology Mayo Clinic
Scottsdale, Arizona, 85259
Italy1 site
Internal Medicine & Gastroenterology, University of Bologna,
Bologna, I-40138
Sweden1 site
Departement of Internal Medicine, Sahlgrenska Universitetss
Gothenburg, 41345
About this study
Official title: Intestinal Motility Evaluation by Endoluminal Image Analysis Using Capsule Endoscopy (CE-EIA): a Multi-center Clinical Trial
Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world.
A novel method for evaluation of intestinal motility has been developed based on endoluminal image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is fully automated by a computer program.
Read more
The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.
This technique needs now to be validated in a large multinational population, to further develop a robust discrimination algorithm for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.
This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.
Read the detailed description
Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility1,2,3,11, and identifies patterns of intestinal dysmotility4,8,9. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients. Furthermore, it requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world6,7,10,13.
Vall d'Hebron Hospital, in collaboration with CVC (Barcelona, Spain) have recently developed a minimally invasive method for evaluation of intestinal motility based on endoluminal image analysis using the endoscopic PillCam capsule. In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is performed fully automated by a computer program. Both the technical procedure of the test and the endoluminal image analysis program has been developed by a multidisciplinary medical-engineering team in the Autonomous University of Barcelona over the past 5 years. The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.
In brief, the technique works as follows. In each study a series of features are analyzed: contractile patterns (contractions evaluated as a diaphragmatic occlusion of the lumen and by the presence of a radial wrinkle pattern), non contractile patterns (wall and tunnel patterns), luminal content (turbid pattern), endoluminal motion, and capsule displacement.
The program is based on an automated learning method (machine learning technique). Data from patients and healthy subjects are used as a training set. Based on these data, the program develops the function that best discriminates both groups. The performance of the system has been validated using the leave-one-out method that uses all but one as training set and evaluates the left-out example.
This technique needs now to be validated in a large multinational population. Using this expanded pool of studies as a learning set, a robust discrimination algorithm will be developed, that can be made available for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic5,12 and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.
This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.
- Conditions
- Intestinal Abnormalities
- Being tested
- PillCam SB2
- Keywords
- intestinal abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam SB2Device
The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Patients previously indicated for manometry Receives: Device: PillCam SB2 |
| Healthy volunteers | Active comparator | Healthy volunteers Receives: Device: PillCam SB2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility
Patients were indicated for small bowel manometry based on one or both of the following symptoms:
- Pseudo obstruction
- Unintentional body weight loss
Measured: Up to 7 months
Secondary outcomes (1)
To Assess Correlation Between Patient Clinical Symptoms and CE-EIA
The study was terminated without achieving the needed sample size due to very low recruitment rate. Therefore, no statistical analysis has been performed to achieve the secondary outcome.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionJun 2013
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 Intestinal AbnormalitiesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Azpiroz, Prof., Principal investigator, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085513
- Sponsor's protocol ID
- MA-68
- Status last verified
- Jan 2020
- First submitted
- 11 Mar 2010
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Motility Evaluation by Endoluminal Image Analysis Using Capsule Endoscopy (CE-EIA): a Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT01085513
- Acronym / sponsor ID
- MA-68
- Conditions
- Intestinal Abnormalities
- Keywords
- intestinal abnormalities
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Posted 23 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world.
A novel method for evaluation of intestinal motility has been developed based on endoluminal image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is fully automated by a computer program.
The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.
This technique needs now to be validated in a large multinational population, to further develop a robust discrimination algorithm for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.
This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.
Detailed description
Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility1,2,3,11, and identifies patterns of intestinal dysmotility4,8,9. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients. Furthermore, it requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world6,7,10,13.
Vall d'Hebron Hospital, in collaboration with CVC (Barcelona, Spain) have recently developed a minimally invasive method for evaluation of intestinal motility based on endoluminal image analysis using the endoscopic PillCam capsule. In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is performed fully automated by a computer program. Both the technical procedure of the test and the endoluminal image analysis program has been developed by a multidisciplinary medical-engineering team in the Autonomous University of Barcelona over the past 5 years. The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.
In brief, the technique works as follows. In each study a series of features are analyzed: contractile patterns (contractions evaluated as a diaphragmatic occlusion of the lumen and by the presence of a radial wrinkle pattern), non contractile patterns (wall and tunnel patterns), luminal content (turbid pattern), endoluminal motion, and capsule displacement.
The program is based on an automated learning method (machine learning technique). Data from patients and healthy subjects are used as a training set. Based on these data, the program develops the function that best discriminates both groups. The performance of the system has been validated using the leave-one-out method that uses all but one as training set and evaluates the left-out example.
This technique needs now to be validated in a large multinational population. Using this expanded pool of studies as a learning set, a robust discrimination algorithm will be developed, that can be made available for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic5,12 and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.
This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Device: PillCam SB2Patients previously indicated for manometry |
| Healthy volunteers | Active comparator | Device: PillCam SB2Healthy volunteers |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Patient's age is 16-80 years, inclusive.
- One of the following SB manometry procedures:
- Patient was indicated for small bowel manometry based on one or both of the following symptoms:
- recurrent acute episodes (at least two) with air fluid levels (as evidenced at least once by abdominal X-ray), or
- chronic symptoms with small bowel dilation resembling a partial mechanical obstruction.
Key exclusion criteria (13 listed)
- Acute exacerbation of chronic obstructive symptoms.
- Mechanical obstruction of any kind such as definite long stricture seen on radiological exam.
- Suspected GI stricture, followed by Agile® study that could not prove patency of the GI tract.
- Known history of small bowel organic disease such as Crohn's Disease or Celiac.
- Patient suffers from any condition, such as swallowing problems or having an implanted cardiac pacemaker or defibrillator which precludes compliance with study and/or device instructions.
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 SB2The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body. | Device | Healthy volunteers, Patients |
Primary outcome
To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility
Time frame: Up to 7 months
Patients were indicated for small bowel manometry based on one or both of the following symptoms: * Pseudo obstruction * Unintentional body weight loss
1 secondary outcome
To Assess Correlation Between Patient Clinical Symptoms and CE-EIA
Time frame: Up to 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Fernando Azpiroz, Prof. principal investigator
Universitat Autonoma de Barcelona
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam SB2 in people with Intestinal Abnormalities, run by Medtronic - MITG at 6 sites in 5 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 23 inclusion and 13 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Belgium, Italy, Spain, Sweden. 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 23 Jun 2014). 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?
To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility (time frame: Up to 7 months). 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 22 Jul 2020.