Who is eligible for clinical trial NCT06445504?

Participants must meet protocol criteria for Inguinal Hernia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06445504 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-13

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair) (NCT06445504)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Medtronic - MITG

🩺 Plain-English Summary (8th-Grade Level)

A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system. Subjects will be followed through two years. This study will be conducted using up to ten investigative sites in the United States (US).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (17 items).

Location: Tampa General Hospital — Tampa, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Adult subjects (age ≥ 22 years) as required by local law
Subject has been indicated for one of the following hernia repairs: (a.) primary or incisional ventral hernia(s). Multiple small hernia defects are allowed with total distance of combined defects being \< 10cm (b.) inguinal (unilateral or bilateral) hernia(s).
Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients for which minimally invasive surgery is contraindicated as determined by the Investigator
Patients with a recurrent hernia
Subjects with femoral hernia defects
Subjects with ventral hernia defect(s) located in M1, M5, or L4
Patients with emergent hernia repair
Ventral hernia is CDC (Center for Disease Control) grade 2 or higher
Use of component separation techniques to close the hernia defect
Inability to close the hernia defect
Hernia defect is ≥ 10 cm
Patient has BMI \> 40
Patients with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

Tampa General Hospital — Tampa, Florida
University of Illinois, Chicago — Chicago, Illinois
University of Buffalo — Buffalo, New York
Duke University — Durham, North Carolina
Cleveland Clinic — Cleveland, Ohio
UT Health — Houston, Texas
Bon Secours — Newport News, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗