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NCT01828892: FG-treatment

A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas

Status unknown NA Last updated 9 June 2015
What this trial tests

NA trial testing Endoscopy exploration and glue application in Low-output External Gastrointestinal Fistula in 30 participants. Status unknown.

Timeline
1 March 2014
Primary endpoint
1 June 2017
1 December 2017

Quick facts

Lead sponsorJinling Hospital, China
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 March 2014
Primary completion1 June 2017
Estimated completion1 December 2017
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jinling Hospital, China

Who can join

Adults 18 to 65, any sex, with Low-output External Gastrointestinal Fistula. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.
    Wu X, Ren J, Wang G, Wang J, et al · · 2015 · cited 7× · PMID 26445823 · DOI 10.1186/s13063-015-0966-9

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Other Jinling Hospital, China 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/NCT01828892.

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