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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.

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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.

Primary Outcome

The depth of insertion was defined as the maximum distance the enteroscope was inserted past the pylorus. In SBE, the endoscopist estimates in 10cm increments from 0 to 40 cm the length of small bowel released during each insertion of the overtube and pulling back of the enteroscope and overtube. The net advancement is defined as the DMI for SBE. For SE the DMI is calculated by counting the length of bowel examined in 10-cm increments upon withdrawal of the enteroscope and overtube.

Interventions

  • PROCEDURE Single Balloon
  • PROCEDURE Spirus

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-05
Est. Completion 2011-01
Johns Hopkins University

1,448 total trials

Why NCT01853241 stopped before completion

NCT01853241 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which Single Balloon is the first listed.

NCT01853241 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT01853241, the US trial registry maintained by the National Library of Medicine. NCT01853241 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.