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NCT01085513 · ClinicalTrials.gov registry record · NA
Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy
A NA study, sponsored by Medtronic - MITG.
- Terminated
- Registry status
- NA
- Development phase
- 143
- Enrollment target
NCT01085513 is a NA study that was terminated before completion, run by Medtronic - MITG. The registered enrollment target is 143 participants.
The verdict
NCT01085513, a NA study, was terminated before completion, sponsored by Medtronic - MITG.
- TERMINATED
- Registry status
- NA
- Development phase
- 143 participants
- Enrollment target
Study 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 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.
Interventions
- DEVICE PillCam SB2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01085513
The ClinicalTrials.gov registry entry for NCT01085513 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic - MITG, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PillCam SB2 is the first listed.
NCT01085513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01085513 about?
NCT01085513 is a clinical study titled "Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy". 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 ex...
What is the current status of trial NCT01085513?
This trial is currently terminated. It is a NA study. The enrollment target is 143 participants. The study started on 2009-02. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01085513?
The interventions under investigation include: PillCam SB2 (DEVICE).
Who is sponsoring clinical trial NCT01085513?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
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