PEG by Introducer Method Via EG Scan

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02183207
• Collaborator: IntroMedic Co., Ltd. (Industry)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia; Aspiration; Esophageal Stenosis	Procedure: Percutaneous Endoscopic Gastrostomy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM
• Study Start Date: Aug 1, 2013
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Aug 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The success rate of PEG via introducer method by visualization through EG ScanTM [up to 1 year from PEG insertion]

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

Secondary Outcome Measures

1. Complication rate [up to one year from PEG insertion]

   Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St Mary's Hospital	Seoul		Korea, Republic of	137-701

Sponsors and Collaborators

• The Catholic University of Korea
• IntroMedic Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Myung-gui Choi, Professor, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT02183207
• Other Study ID Numbers: PEG by EG Scan
• First Posted: Jul 8, 2014
• Last Update Posted: Jul 8, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Myung-gui Choi, Professor, The Catholic University of Korea: percutaneous endoscopic gastrostomy; Introducer method
• Additional relevant MeSH terms: Esophageal Stenosis

Study Results

No Results Posted as of Jul 8, 2014