Nutrient Intake DisorderNCT04222179
One Brand-new Maneuver to Place Nasoenteric Tube
A study testing ultrathın esophagogastroduodenoscope in people with Nutrient Intake Disorder, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Naso-enteric tube feeding is necessary for certain patients. Many methods are used to place a naso-enteric tube, such as bed-side blind method, fluoroscopy method and guide-wire method. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Nutrient Intake Disorder
- What is being tested?
- ultrathın esophagogastroduodenoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 31 Dec 2020
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Esophageal obstruction
- Gastric outlet obstruction
- Duodenal obstruction
- Pancreatitis
- Gastroparesis -
Who cannot join
- (1)Coagulopathy (2)Deviation of nasal septa (3)Conscious disturbance
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tzu-chi Hospital
Hualien City, Hua-lien County, 97002
Jen S Lin, VS, 886-3-8561825 ext. 13224, labyrinth68306830@icloud.com
About this study
Official title: Tzu-chi General Hospital,Hualien County,Taiwan,ROC
Naso-enteric tube feeding is necessary for certain patients. Many methods are used to place a naso-enteric tube, such as bed-side blind method, fluoroscopy method and guide-wire method. INvestigators aim to introduce a safe, non-expensive and fast method to insert a silicon naso-gastric (NG) tube into the small intestine.
Read the detailed description
Investigators tied a 1-cm surgical suture at the tip of a 16 French silicon NG tube (120 cm long, cost 5 US dollars). One conventional EGD (diameter 2.8 mm) biopsy forceps was inserted into the lumen as a strengthened stylet. Then investigators inserted a biopsy forceps (diameter 2.0 mm) and protruded a little out of the working channel of an ultrathin EGD scope (Fujinon EG 530 N, diameter 5.9 mm) to grasp the suture. The ultrathin EGD and NG tube were parallelly pushed into a selected nostril after adequate decongestive anesthesia (Epinephrine 0.3% + Lidocaine 5%) into the small intestine as deep as possible to the jejunum.
Being placed to the small intestine as far as possible, the NG tube was released and the ultrathin EGD scope withdrew. When the scope was pulled backwards from the stomach, the shape/layout of a NG-tube could be simultaneously monitored and adjusted. At last, the EGD biopsy forceps (2.8 mm) inside the NG tube was removed. With this method, in real life, a plain film is not necessary to confirm the NG tube position. However, for study purpose, a KUB film was taken to check the NG tube position.
- Conditions
- Nutrient Intake Disorder
- Being tested
- ultrathın esophagogastroduodenoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrathın esophagogastroduodenoscopeDevice
Place the naso-enteric tube together with the ultrathin esophagogastroduodenoscope from the same nasal cavity
| Study group | Role | What they receive |
|---|---|---|
| Naso-enteric tube placement | Other | The participants needed nutrition from naso-enteric tube feeding are enrolled into this study. Double-blind was not needed here. Receives: Device: ultrathın esophagogastroduodenoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure time
The procedure times to place the tube are recorded
Measured: wıthın 20 mınutes
Secondary outcomes (1)
the tıme of naso-enterıc tube usage
The tıme of the naso-enteric tube was recorded in day
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient Intake DisorderStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jen-Shung Lin, Buddhist Tzu Chi General Hospital
- Investigators
- Jen S Lin, VS, Study director, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222179
- Sponsor's protocol ID
- IRB106-10-A
- Status last verified
- Jul 2020
- First submitted
- 2 Jan 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tzu-chi General Hospital,Hualien County,Taiwan,ROC
- ClinicalTrials.gov ID
- NCT04222179
- Acronym / sponsor ID
- IRB106-10-A
- Conditions
- Nutrient Intake Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Jan 2020 (actual)
- 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.
Naso-enteric tube feeding is necessary for certain patients. Many methods are used to place a naso-enteric tube, such as bed-side blind method, fluoroscopy method and guide-wire method. INvestigators aim to introduce a safe, non-expensive and fast method to insert a silicon naso-gastric (NG) tube into the small intestine.
Detailed description
Investigators tied a 1-cm surgical suture at the tip of a 16 French silicon NG tube (120 cm long, cost 5 US dollars). One conventional EGD (diameter 2.8 mm) biopsy forceps was inserted into the lumen as a strengthened stylet. Then investigators inserted a biopsy forceps (diameter 2.0 mm) and protruded a little out of the working channel of an ultrathin EGD scope (Fujinon EG 530 N, diameter 5.9 mm) to grasp the suture. The ultrathin EGD and NG tube were parallelly pushed into a selected nostril after adequate decongestive anesthesia (Epinephrine 0.3% + Lidocaine 5%) into the small intestine as deep as possible to the jejunum.
Being placed to the small intestine as far as possible, the NG tube was released and the ultrathin EGD scope withdrew. When the scope was pulled backwards from the stomach, the shape/layout of a NG-tube could be simultaneously monitored and adjusted. At last, the EGD biopsy forceps (2.8 mm) inside the NG tube was removed. With this method, in real life, a plain film is not necessary to confirm the NG tube position. However, for study purpose, a KUB film was taken to check the NG tube position.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naso-enteric tube placement | Other | Device: ultrathın esophagogastroduodenoscopeThe participants needed nutrition from naso-enteric tube feeding are enrolled into this study. Double-blind was not needed here. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Esophageal obstruction
- Gastric outlet obstruction
- Duodenal obstruction
- Pancreatitis
- Gastroparesis -
Key exclusion criteria (1 listed)
- (1)Coagulopathy (2)Deviation of nasal septa (3)Conscious disturbance
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 |
|---|---|---|
| ultrathın esophagogastroduodenoscopePlace the naso-enteric tube together with the ultrathin esophagogastroduodenoscope from the same nasal cavity | Device | Naso-enteric tube placement |
Primary outcome
procedure time
Time frame: wıthın 20 mınutes
The procedure times to place the tube are recorded
1 secondary outcome
the tıme of naso-enterıc tube usage
Time frame: within 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Jen S Lin, VS study director
Buddhist Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrathın esophagogastroduodenoscope in people with Nutrient Intake Disorder, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 5 inclusion and 1 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 10 Jul 2020. 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 Taiwan. 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?
Contact Jen S Lin, VS (886-3-8561825 ext. 13224, labyrinth68306830@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedure time (time frame: wıthın 20 mınutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2020.