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NCT01411488 · ClinicalTrials.gov registry record · NA

Comparative Study Between Two Fecal Management Systems

A NA study of Anal Erosion, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
90
Enrollment target
1
Study location

NCT01411488: Completed NA study of Anal Erosion, sponsored by The Cleveland Clinic.

NCT01411488 is a NA study of Anal Erosion that has completed, run by The Cleveland Clinic. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% 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

NCT01411488, a NA study of Anal Erosion, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
90 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to determine the prevalence of anal erosions within a 14 day period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal management systems (FMS). Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal management systems in a 14 day period. Alternative Hypothesis: One fecal management system is no worse than the second fecal management system in the development of anal erosion.

Primary Outcome

anal erosion within 14 days after insertion of FMS

Conditions Studied

Interventions

  • DEVICE Fecal management system

Study Locations (1)

Ohio

  • Cleveland Clinic Main Campus - Cleveland

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2011-01
Est. Completion 2012-05
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT01411488 record still lists

NCT01411488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Anal Erosion appearing as the primary indexed condition, and to 1 intervention - of which Fecal management system is the first listed.

NCT01411488 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT01411488 about?

NCT01411488 is a clinical study titled "Comparative Study Between Two Fecal Management Systems". The purpose of the study is to determine the prevalence of anal erosions within a 14 day period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal management systems (FMS). Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal ...

What is the current status of trial NCT01411488?

This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2011-01. Estimated completion is 2012-05.

What conditions does trial NCT01411488 study?

This clinical trial studies the following conditions: Anal Erosion.

What interventions are being tested in trial NCT01411488?

The interventions under investigation include: Fecal management system (DEVICE).

Who is sponsoring clinical trial NCT01411488?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01411488 being conducted?

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

How this trial's enrollment target compares

Where NCT01411488's enrollment target sits among peer trials

90 941st of 2000 higher than 1,029 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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Source: ClinicalTrials.gov NCT01411488, the US trial registry maintained by the National Library of Medicine. NCT01411488 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.