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NCT01113736 · ClinicalTrials.gov registry record · Phase 1

Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

A Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT01113736: Completed Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.

NCT01113736 is a Phase 1 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01113736, a Phase 1 study, has completed, sponsored by University Hospitals Cleveland Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.

Primary Outcome

Change in adhesion formation will be analyzed via the primary outcome of ileostomy mobilization time during ileostomy closure and the secondary outcome of an adhesion grading scale.

Interventions

  • BIOLOGICAL AlloMEM™

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2010-01
Est. Completion 2012-07
Phase Phase 1

What the finished NCT01113736 record still lists

NCT01113736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which AlloMEM™ is the first listed.

NCT01113736 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01113736 about?

NCT01113736 is a clinical study titled "Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy". The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, wi...

What is the current status of trial NCT01113736?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-01. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01113736?

The interventions under investigation include: AlloMEM™ (BIOLOGICAL).

Who is sponsoring clinical trial NCT01113736?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01113736's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01113736, the US trial registry maintained by the National Library of Medicine. NCT01113736 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.