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NCT00517296 · ClinicalTrials.gov registry record · Phase 4

Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

A Phase 4 study of Crohn Disease and Rectal Fistula, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 4
Development phase
21
Enrollment target
1
Study location

NCT00517296: Completed Phase 4 study of Crohn Disease and Rectal Fistula, sponsored by Vanderbilt University Medical Center.

NCT00517296 is a Phase 4 study of Crohn Disease and Rectal Fistula that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 21 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00517296, a Phase 4 study of Crohn Disease and Rectal Fistula, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
21 participants
Enrollment target
1
Study location

Study Summary

This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.

Primary Outcome

Complete cessation of fistula drainage at 48 weeks

Interventions

  • PROCEDURE EUA with seton placement if necessary
  • DRUG adalimumab
  • PROCEDURE EUS

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2008-01
Est. Completion 2015-12
Phase Phase 4

What the finished NCT00517296 record still lists

NCT00517296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (90% lower).

The record links to 2 conditions, with Crohn Disease appearing as the primary indexed condition, and to 3 interventions - of which EUA with seton placement if necessary is the first listed.

NCT00517296 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT00517296 about?

NCT00517296 is a clinical study titled "Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas". This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.

What is the current status of trial NCT00517296?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2008-01. Estimated completion is 2015-12.

What conditions does trial NCT00517296 study?

This clinical trial studies the following conditions: Crohn Disease, Rectal Fistula.

What interventions are being tested in trial NCT00517296?

The interventions under investigation include: EUA with seton placement if necessary (PROCEDURE), adalimumab (DRUG), EUS (PROCEDURE).

Who is sponsoring clinical trial NCT00517296?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00517296 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Crohn Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00517296's enrollment target sits among peer trials

21 61st of 71 higher than 10 of 71 other Crohn Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Crohn Disease 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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Source: ClinicalTrials.gov NCT00517296, the US trial registry maintained by the National Library of Medicine. NCT00517296 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.