NCT04222179

Brief 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. INvestigators aim to introduce a safe, non-expensive and fast method to insert a silicon naso-gastric (NG) tube into the small intestine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

January 2, 2020

Last Update Submit

July 8, 2020

Conditions

Nutrient Intake Disorder

Outcome Measures

Primary Outcomes (1)

  • procedure time

    The procedure times to place the tube are recorded

    wıthın 20 mınutes

Secondary Outcomes (1)

  • the tıme of naso-enterıc tube usage

    within 90 days

Study Arms (1)

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.

Device: ultrathın esophagogastroduodenoscope

Interventions

ultrathın esophagogastroduodenoscopeDEVICE

Place the naso-enteric tube together with the ultrathin esophagogastroduodenoscope from the same nasal cavity

Naso-enteric tube placement

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Esophageal obstruction
  • Gastric outlet obstruction
  • Duodenal obstruction
  • Pancreatitis
  • Gastroparesis -

You may not qualify if:

  • (1)Coagulopathy (2)Deviation of nasal septa (3)Conscious disturbance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tzu-chi Hospital

Hualien City, Hua-lien County, 97002, Taiwan

RECRUITING

Study Officials

  • Jen S Lin, VS

    Buddhist Tzu Chi General Hospital

    STUDY DIRECTOR

Central Study Contacts

Jen S Lin, VS

CONTACT

886-3-8561825labyrinth68306830@icloud.com

Chi T Hu, VS

CONTACT

886-3-8561825chitan.hu@msa.hinet.net

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
Prıncıpal ınvestıgator

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 9, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)