PEG by Introducer Method Via EG Scan

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02183207
• Other study ID #: PEG by EG Scan
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2013
• Last updated: July 2, 2014
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: July 2014
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspiration
• Dysphagia
• Esophageal Stenosis

Intervention

Procedure:
• Percutaneous Endoscopic Gastrostomy
Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	IntroMedic Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 1 year from PEG insertion	No
Secondary	Complication rate	Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents	up to one year from PEG insertion	Yes