DysphagiaNCT02183207
PEG by Introducer Method Via EG Scan
A study testing Percutaneous Endoscopic Gastrostomy in people with Dysphagia and Aspiration, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dysphagia, Aspiration, Esophageal Stenosis
- What is being tested?
- Percutaneous Endoscopic Gastrostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St Mary's Hospital
Seoul, 137-701
Myong Ki Baeg, MD, 82-2-2258-2045, biosoul@hanmail.net
Chul-Hyun Lim, MD, PhD, 82-2-2258-2046, djluck@hanmail.net
About this study
Official title: Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM
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.
- Conditions
- Dysphagia, Aspiration, Esophageal Stenosis
- Being tested
- Percutaneous Endoscopic Gastrostomy
- Keywords
- percutaneous endoscopic gastrostomy, Introducer method
- Medical subject headings
- Deglutition Disorders, Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Endoscopic GastrostomyProcedure or surgery
Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM
| Study group | Role | What they receive |
|---|---|---|
| PEG insertion arm via EG Scan | Experimental | Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM Receives: Procedure: Percutaneous Endoscopic Gastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year from PEG insertion
Secondary outcomes (1)
Complication rate
Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents
Measured: up to one year from PEG insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- IntroMedic Co., Ltd.
- Responsible party
- Principal investigator, Myung-gui Choi, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183207
- Sponsor's protocol ID
- PEG by EG Scan
- Status last verified
- Jul 2014
- First submitted
- 11 Aug 2013
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16771943Yuki 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.
PubMed 19938199
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM
- ClinicalTrials.gov ID
- NCT02183207
- Acronym / sponsor ID
- PEG by EG Scan
- Conditions
- Dysphagia, Aspiration, Esophageal Stenosis
- Keywords
- percutaneous endoscopic gastrostomy, Introducer method
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- IntroMedic Co., Ltd.
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG insertion arm via EG Scan | Experimental | Procedure: Percutaneous Endoscopic GastrostomyPercutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Endoscopic GastrostomyPercutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM | Procedure or surgery | PEG insertion arm via EG Scan |
Primary outcome
The success rate of PEG via introducer method by visualization through EG ScanTM
Time frame: up to 1 year from PEG insertion
up to 1 year from PEG insertion or until patient death if within one year
1 secondary outcome
Complication rate
Time frame: up to one year from PEG insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Results publication: PubMed 16771943Dormann 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.
- Results publication: PubMed 19938199Yuki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Endoscopic Gastrostomy in people with Dysphagia and Aspiration, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of PEG via introducer method by visualization through EG ScanTM (time frame: up to 1 year from PEG insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02183207, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.