Aspiration, Dysphagia, Esophageal Stenosis
Conditions
Keywords
percutaneous endoscopic gastrostomy, Introducer method
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.
Interventions
PROCEDUREPercutaneous Endoscopic Gastrostomy
Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM
Sponsors
IntroMedic Co., Ltd.
The Catholic University of Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | up to one year from PEG insertion | Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents |
Countries
South Korea
Outcome results
None listed