Completed

Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

+ other Data

+ other Data

Collected from today forward - Prospective
Other
Who is being recruted

From 18 to 90 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2012
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo
Last updated: October 3, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each,in patients submitted to long-term outpatient nutritional support. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.This study is important because tube dysfunction and unscheduled changes are expensive troubles that disrupt the nutritional protocol and are responsible for multiple inconveniences to the patient and the caretaker.

NCT01698827
Principal SponsorUniversity of Sao Paulo
Last updated: October 3, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Adults undergoing long-term home enteral nutrition via percutaneous endoscopic gastrostomy due to neurologic conditions or dysphagia
clinical stable and with the possibility of returning for scheduled visits
expected duration of enteral feeding > 6 months
registered at the outpatient endoscopy service
7 exclusion criteria prevent from participating
Sepsis
coma
lack of cooperation
other types of digestive access (surgical gastrostomy, jejunostomy)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077

São Paulo, BrazilOpen Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077 in Google Maps

Hospital das Clinicas

São Paulo, Brazil
Completed2 Study Centers