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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02183207
Other study ID # PEG by EG Scan
Secondary ID
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


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
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