PEG by Introducer Method Via EG Scan
Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJuly 8, 2014
July 1, 2014
1.9 years
August 11, 2013
July 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Complication rate
up to one year from PEG insertion
Study Arms (1)
PEG insertion arm via EG Scan
EXPERIMENTALPercutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM
Interventions
Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM
Eligibility Criteria
You may qualify if:
- Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Catholic University of Korealead
- IntroMedic Co., Ltd.collaborator
Study Sites (1)
Seoul St Mary's Hospital
Seoul, 137-701, South Korea
Related 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. doi: 10.1111/j.1572-0241.2006.00541.x.
PMID: 16771943RESULTYuki 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.
PMID: 19938199RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 11, 2013
First Posted
July 8, 2014
Study Start
August 1, 2013
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
July 8, 2014
Record last verified: 2014-07