PEG by Introducer Method Via EG Scan

July 2, 2014 updated by: Myung-gui Choi, The Catholic University of Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEG insertion arm via EG Scan
Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM
Procedure: Percutaneous Endoscopic Gastrostomy
Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 year from PEG insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: up to one year from PEG insertion
Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents
up to one year from PEG insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

IntroMedic Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

August 11, 2013

First Submitted That Met QC Criteria

July 2, 2014

First Posted (ESTIMATE)

July 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEG by EG Scan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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