CompletedNot Applicable

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

Brazil100 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults undergoing long-term home enteral nutrition via percutaneous endoscopic gastrostomy due to neurologic conditions or dysphagia. * registered at the outpatient endoscopy service * clinical stable and with the possibility of returning for scheduled visits * expected duration of enteral feeding \> 6 months Exclusion Criteria: * Sepsis, * shock, * coma, * other types of digestive access (surgical gastrostomy, jejunostomy) * terminal disease, * lack of cooperation, * refusal to participate in the protocol

What they're measuring

Tube durability

Timeframe: 6 months

Trial details

NCT IDNCT01698827

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Gastrostomy Tube Rupture trials