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Clinical Trials/NCT02183207
NCT02183207
Unknown
Not Applicable

Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM

The Catholic University of Korea1 site in 1 country24 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphagia
Sponsor
The Catholic University of Korea
Enrollment
24
Locations
1
Primary Endpoint
The success rate of PEG via introducer method by visualization through EG ScanTM
Last Updated
11 years ago

Overview

Brief Summary

Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and easy to perform. However, it is limited by its need to be performed in an endoscopy unit. E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any hospital setting and introduced via nasal approach. Our aim is to prove that PEG by introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at hospitals and medical facilities without endoscopic units.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
August 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Myung-gui Choi

Professor

The Catholic University of Korea

Eligibility Criteria

Inclusion Criteria

  • Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month

Exclusion Criteria

  • Patients with esophageal ulcers or strictures
  • Patients with prior esophageal/gastric surgery (excepting gastric wedge resection)
  • Patients at high risk of gastric bleeding, mechanical ileus or gastrointestinal perforation
  • Other patients in whom the study investigators consider unfit for inclusion

Outcomes

Primary Outcomes

The success rate of PEG via introducer method by visualization through EG ScanTM

Time Frame: up to 1 year from PEG insertion

up to 1 year from PEG insertion or until patient death if within one year

Secondary Outcomes

  • Complication rate(up to one year from PEG insertion)

Study Sites (1)

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