Intestinal Abnormalities Clinical Trial
Official title:
Intestinal Motility Evaluation by Endoluminal Image Analysis Using Capsule Endoscopy (CE-EIA): a Multi-center Clinical Trial
| NCT number | NCT01085513 |
| Other study ID # | MA-68 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2009 |
| Est. completion date | June 2013 |
| Verified date | January 2020 |
| Source | Medtronic - MITG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 143 |
| Est. completion date | June 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 16 Years to 80 Years |
| Eligibility |
Inclusion criteria - Patients - 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: - 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 Exclusion criteria - Patients - 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. - 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. Inclusion criteria - Healthy Volunteers - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Center for GI Research, KU Leuven, | Leuven | |
| Italy | Internal Medicine & Gastroenterology, University of Bologna, | Bologna | |
| Spain | Autonomous University of Barcelona | Barcelona | |
| Sweden | Departement of Internal Medicine, Sahlgrenska Universitetss | Göteborg | |
| United States | Mayo Clinic, | Rochester | Minnesota |
| United States | Division of Gastroenterology and Hepatology Mayo Clinic | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic - MITG |
United States, Belgium, Italy, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
Up to 7 months | |
| Secondary | 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. | Up to 7 months |