MedTrace Logo

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

NCT01698827 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2012-10-03

No results posted yet for this study

Summary

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. 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.

Conditions

  • Gastrostomy Tube Rupture
  • Gastrostomy Tube Durability
  • Gastrostomy Tube Convenience

Interventions

OTHER

Tube assessment visits

Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Joel Faintuch, MD, PhD · Hospital das Clinicas, Sao Paulo, Brazil

  • Paulo Sakai, MD, PhD · Hospital das Clinicas, Sao Paulo, Brazil

  • Emanuele L Villela, MD · Hospital das Clinicas, Sao Paulo, Brazil

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01698827 on ClinicalTrials.gov