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Biologic Augmented Repair for Anal Fistulas (BIO RAMP Trial)

N/A

Recruiting

Led By Jeffrey L Van Eps, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.

Awards & highlights

BIO RAMP Trial Summary

This trial compares the effects of augmenting complex anal fistula repair with PRP and/or UBM vs usual care on post-op pain, fecal continence, and cost-effectiveness.

Who is the study for?

This trial is for English or Spanish speakers who can consent and have complex anal fistulas needing surgery. Surgeons must do at least 3 repairs a year. Patients should be willing to have temporary drainage before repair but can't join if they can't follow up for a year, have platelet disorders, very low platelet counts, take certain blood thinners, or their fistula is due to IBD, cancer, or radiation.Check my eligibility

What is being tested?

The study tests if adding autologous PRP (from the patient's own blood) and/or porcine urinary bladder matrix improves healing after anal fistula surgery compared to usual care alone. It looks at recurrence rates, quality of life post-surgery, pain levels, fecal continence and cost-effectiveness.See study design

What are the potential side effects?

Potential side effects may include discomfort from PRP injections and risks associated with surgical procedures such as infection or issues with wound healing. The specific side effects of the urinary bladder matrix are not detailed but could involve similar surgical risks.

BIO RAMP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire

Number of participants with fistula recurrence

Secondary outcome measures

Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool

Number of participants who have post operative pain as assessed by the visual analog scale (VAS)

The relative cost utility of the different treatment strategies as assessed by a questionnaire

BIO RAMP Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Surgery plus platelet-rich plasma (PRP)Experimental Treatment2 Interventions

Group II: Surgery plus matrixExperimental Treatment2 Interventions

Group III: Surgery plus PRP plus matrix materialExperimental Treatment3 Interventions

Group IV: SurgeryPlacebo Group1 Intervention

Control patients will receive usual standard of care surgical repair of their complex fistula by The ligation of intersphincteric tract (LIFT) or advancement flap technique without any biologic adjunct.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matrix

2015

N/A

~10

Surgery

2000

Completed Phase 3

~2550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUNKNOWN

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,710 Total Patients Enrolled

Jeffrey L Van Eps, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Surgery plus platelet-rich plasma (PRP) Clinical Trial Eligibility Overview. Trial Name: NCT05805449 — N/A

Anal Fistulas Research Study Groups: Surgery, Surgery plus platelet-rich plasma (PRP), Surgery plus matrix, Surgery plus PRP plus matrix material

Anal Fistulas Clinical Trial 2023: Surgery plus platelet-rich plasma (PRP) Highlights & Side Effects. Trial Name: NCT05805449 — N/A

Surgery plus platelet-rich plasma (PRP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05805449 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial recruiting participants at the present moment?

"Per the information provided on clinicaltrials.gov, this study is currently recruiting patients and was initially posted in February 21st 2023 with subsequent alterations made in April 5th 2023."

Answered by AI

How many participants have enrolled in this research project?

"Affirmative. Information on clinicaltrials.gov demonstrates that this research is actively inviting study volunteers, considering the trial was first posted on February 21st of 2023 and later updated on April 5th of the same year. At present, they are looking to enroll 250 participants at a single site."

Answered by AI

Who else is applying?

What state do they live in?

Arizona

What site did they apply to?

The University of Texas Health Science Center at Houston

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I am feel like there is no hope and I am in pain everyday. I no longer have a life. I have a 4 year old son and I find it difficult to do any any thin with him. I feel like a haven't slept due to the excruciating pain most of the time. Dr's tell me all of this is normal.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

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

Jeff Van Eps, MD 2023. "BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05805449.

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