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NCT03920306: GCF

A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children

Status unknown Phase 4 Last updated 21 January 2022
What this trial tests

Phase 4 trial testing oral anti-acid treatment in Gastrocutaneous Fistula in 100 participants. Status unknown.

Timeline
1 April 2019
Primary endpoint
1 April 2023
1 October 2023

Quick facts

Lead sponsorUniversity of British Columbia
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment100
Start date1 April 2019
Primary completion1 April 2023
Estimated completion1 October 2023
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

Under 18, any sex, with Gastrocutaneous Fistula or Gastrostomy Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastrostomy tube placement is a common surgery, and involves placing a tube from the child's skin to the inside of their stomach, allowing an alternative route for nutrition and medication to patients who cannot tolerate oral intake. A common complication of gastrostomy tubes is the development of a persistent connection between the stomach and skin after their removal. This is called a gastrocutaneous fistula (GCF). Non-surgical options have shown some success in eliminating the need for surgery to close these fistulae. Their true efficacy is unknown however; this study evaluates a non-surgical intervention bundle in the prevention and treatment of GCFs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University of British Columbia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03920306.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing