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NCT01853241 · ClinicalTrials.gov registry record
Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy
A clinical trial, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- 30
- Enrollment target
NCT01853241: Clinical Trial study, sponsored by Johns Hopkins University.
NCT01853241 is a clinical trial that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01853241 was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- 30 participants
- Enrollment target
Study Summary
The small bowel is poorly suited to standard endoscopy techniques due to its anatomical differences from the colon and the upper gastrointestinal tract. The small bowel has an average length of 6.7 m, with a free mesentery that resists standard "push to advance" endoscopy techniques. New developments in overtubes, which are placed over an enteroscope, have revolutionized doctors ability to deeply intubate the small bowel. Three types of 'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE), have been developed. Although studies have been performed on these individual techniques, there are no studies comparing SBE and SE, the two techniques used in Johns Hopkins. The investigators propose performing a prospective, randomised trial, to assess the differences between these two techniques. The question of what differences there are between these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time required for the procedure and the sedation requirements, are important questions to answer, and depending on the results, would affect the investigators approach to patients with small bowel disease.
Interventions
- PROCEDURE Single Balloon
- PROCEDURE Spirus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01853241
The ClinicalTrials.gov registry entry for NCT01853241 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Single Balloon is the first listed.
NCT01853241 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01853241 about?
NCT01853241 is a clinical study titled "Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy". The small bowel is poorly suited to standard endoscopy techniques due to its anatomical differences from the colon and the upper gastrointestinal tract. The small bowel has an average length of 6.7 m, with a free mesentery that resists standard "push to advance" endoscopy techniques. New development...
What is the current status of trial NCT01853241?
This trial is currently terminated. The enrollment target is 30 participants. The study started on 2010-05. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01853241?
The interventions under investigation include: Single Balloon (PROCEDURE), Spirus (PROCEDURE).
Who is sponsoring clinical trial NCT01853241?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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