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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: Clinical Trial NA study, sponsored by Medtronic - MITG.
NCT01085513 is a NA study that was terminated before completion, run by Medtronic - MITG. The registered enrollment target is 143 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients were indicated for small bowel manometry based on one or both of the following symptoms: * Pseudo obstruction * Unintentional body weight loss
Interventions
- DEVICE PillCam SB2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-06 |
| Phase | NA |
Why NCT01085513 stopped before completion
NCT01085513 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which PillCam SB2 is the first listed.
NCT01085513 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01085513's enrollment target sits among peer trials
143 711th of 2000 higher than 1,290 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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