Fort Myers, FLNCT07021742Now EnrollingIRB Ready

Fistula-in-ano Clinical Trial in Fort Myers, FL

Access cutting-edge fistula-in-ano treatment through this clinical trial at a research site in Fort Myers. Study-provided care at no cost to qualified participants.

Sponsored by Signum Surgical USA Inc.

Quick Self-Assessment

See if you qualify for this Fort Myers location

Preparing your pre-screening questions…

Expert Care in Fort Myers

Access fistula-in-ano specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related fistula-in-ano treatment provided free

Apply for This Fort Myers Location

Check if you qualify for this fistula-in-ano clinical trial in Fort Myers, FL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Fort Myers

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Fort Myers site if eligible
  4. 4Begin participation

About This Fistula-in-ano Study in Fort Myers

This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).

Sponsor: Signum Surgical USA Inc.

Who Can Participate

Inclusion Criteria

Age 18 - 75 years
Presence of Single Continuous Anal Fistula presenting for initial curative surgery
Failed or Recurrent Anal Fistula Closure
Minimum of 6-weeks of draining seton placed prior to procedure.
Availability for follow-up contacts and willingness to complete the Informed Consent.

Exclusion Criteria

Fistula tract shorter than 2cm
Complex fistula tract (branching)
Body Mass Index \> 35
Known uncontrolled diabetes or other systemic condition associated with impaired healing
Known HIV-positive or immunocompromised
Rectal prolapse
Rectal / fistula malignancy
Crohn's disease
Ulcerative proctitis
Hidradenitis suppurativa of the anal region
Pilonidal sinus disease
Presence of hemorrhoid Involving fistula site
Continuous use of anti-inflammatory
Intersphincteric fistula in ano or fistula treatable by simple fistulotomy
Active infection or abscess involving fistula site
Known allergy to PLGA material
Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study
Treatment with an investigational drug or medical device in the past 30 days

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fort Myers?

Yes, this clinical trial (NCT07021742) has an active research site in Fort Myers, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Fistula-in-ano Treatment Options in Fort Myers, FL

If you're searching for fistula-in-ano treatment options in Fort Myers, FL, this clinical trial (NCT07021742) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fort Myers research site is actively enrolling participants for this clinical trial. You'll receive care from experienced fistula-in-ano specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Ready to Join in Fort Myers?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Fort Myers, FL