PEG by Introducer Method Via EG Scan

NCT ID: NCT02183207

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia Aspiration Esophageal Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEG insertion arm via EG Scan

Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM

Group Type EXPERIMENTAL

Percutaneous Endoscopic Gastrostomy

Intervention Type PROCEDURE

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

Interventions

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Percutaneous Endoscopic Gastrostomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IntroMedic Co., Ltd.

INDUSTRY

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Myung-gui Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul St Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Myong Ki Baeg, MD

Role: primary

82-2-2258-2045

Chul-Hyun Lim, MD, PhD

Role: backup

82-2-2258-2046

References

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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.

Reference Type RESULT
PMID: 16771943 (View on PubMed)

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.

Reference Type RESULT
PMID: 19938199 (View on PubMed)

Other Identifiers

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PEG by EG Scan

Identifier Type: -

Identifier Source: org_study_id

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