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Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"

NCT01119040 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-01-05

Study results available
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Summary

The purpose of this study is to determine:

1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.
2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.
3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.

Conditions

  • Malnutrition

Interventions

PROCEDURE

Natural Orifice Translumenal Endoscopic Surgery

Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery.

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Marks, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119040 on ClinicalTrials.gov