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NCT05805449: BIO RAMP

BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

Status unknown NA Last updated 10 April 2023
What this trial tests

NA trial testing Surgery in Anal Fistula in 250 participants. Status unknown.

Timeline
21 February 2023
Primary endpoint
28 February 2026
31 March 2026

Quick facts

Lead sponsorThe University of Texas Health Science Center, Houston
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment250
Start date21 February 2023
Primary completion28 February 2026
Estimated completion31 March 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Anal Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Surgery

Trials testing the same drug.

Other recruiting trials for Anal Fistula

Currently open trials in the same condition.

Other The University of Texas Health Science Center, Houston 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/NCT05805449.

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