BioHealx® Anal Fistula Device Post Market Surveillance Study

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Signum Surgical USA Inc.
Study ID
NCT07021742
Status
Recruiting
Apply to this trial

Conditions

  • Fistula-in-ano

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BioHealx — DEVICE
    Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening, preventing reinfection, while allowing for drainage through the external opening during healing.

Study Details

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).

Key Dates

Start date
Jun 14, 2025
Status verified
Aug 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: BioHealx
    Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device.

Primary Outcome Measure

Successful Closure Repair [ Time Frame: 12 Months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
The Colorectal InstituteFort MyersFlorida33912
J Neale, MD
J Neale, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
S Taubes
[email protected]
551-996-4371
S Lee-Kong, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10021
KM Muktasid
[email protected]
646-962-2270
Lea Lowenfeld, MD, FACS, FASCRS (PRINCIPAL_INVESTIGATOR)
Northwell HealthStaten IslandNew York10305
S Belotte
[email protected]
718-226-6398
Poppy Addison, MD (PRINCIPAL_INVESTIGATOR)
Maininle Health LankenauBryn MawrPennsylvania19010
Mainline Health Lankenau
[email protected]
484-476-1000
P Pearson, MD (PRINCIPAL_INVESTIGATOR)
GeisingerDanvillePennsylvania17822
K Rebuck
[email protected]
570-271-6856
Christopher Buzas, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Myers, FL

By research site
The Colorectal Institute· Fort Myers, FLHackensack University Medical Center· Hackensack, NJWeill Cornell Medicine· New York, NYNorthwell Health· Staten Island, NYMaininle Health Lankenau· Bryn Mawr, PAGeisinger· Danville, PA

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