Back to resultsPEG by Introducer Method Via EG Scan
Primary Purpose
Dysphagia, Aspiration, Esophageal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous Endoscopic Gastrostomy
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring percutaneous endoscopic gastrostomy, Introducer method
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
Sites / Locations
- Seoul St Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG insertion arm via EG Scan
Arm Description
Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM
Outcomes
Primary Outcome Measures
The success rate of PEG via introducer method by visualization through EG ScanTM
up to 1 year from PEG insertion or until patient death if within one year
Secondary Outcome Measures
Complication rate
Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents
Full Information
NCT ID
NCT02183207
First Posted
August 11, 2013
Last Updated
July 2, 2014
Sponsor
The Catholic University of Korea
Collaborators
IntroMedic Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02183207
Brief Title
PEG by Introducer Method Via EG Scan
Official Title
Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
IntroMedic Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Aspiration, Esophageal Stenosis
Keywords
percutaneous endoscopic gastrostomy, Introducer method
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEG insertion arm via EG Scan
Arm Type
Experimental
Arm Description
Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Endoscopic Gastrostomy
Intervention Description
Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM
Primary Outcome Measure Information:
Title
The success rate of PEG via introducer method by visualization through EG ScanTM
Description
up to 1 year from PEG insertion or until patient death if within one year
Time Frame
up to 1 year from PEG insertion
Secondary Outcome Measure Information:
Title
Complication rate
Description
Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents
Time Frame
up to one year from PEG insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myong Ki Baeg, MD
Phone
82-2-2258-2045
Email
biosoul@hanmail.net
First Name & Middle Initial & Last Name & Degree
Chul-Hyun Lim, MD, PhD
Phone
82-2-2258-2046
Email
djluck@hanmail.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
16771943
Citation
Dormann AJ, Wejda B, Kahl S, Huchzermeyer H, Ebert MP, Malfertheiner P. Long-term results with a new introducer method with gastropexy for percutaneous endoscopic gastrostomy. Am J Gastroenterol. 2006 Jun;101(6):1229-34. doi: 10.1111/j.1572-0241.2006.00541.x.
Results Reference
result
PubMed Identifier
19938199
Citation
Yuki M, Amano Y, Komazawa Y, Fukuhara H, Shizuku T, Yamamoto S, Kinoshita Y. Unsedated transnasal small-caliber esophagogastroduodenoscopy in elderly and bedridden patients. World J Gastroenterol. 2009 Nov 28;15(44):5586-91. doi: 10.3748/wjg.15.5586.
Results Reference
result
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PEG by Introducer Method Via EG Scan
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