A Prospective Study of Fortiva in Hernia Repair

RTI Surgical

Status: Invitation-only

Conditions: Abdominal Wall Reconstruction; Incisional Hernia; Ventral Hernia

Treatments: Device: Fortiva Tissue Matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT06101979

RTI-2022-01

Details and patient eligibility

About

The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.

Full description

This is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. Safety and performance will be measured after hernia repair for two years.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age at time of consent
• Undergoing hernia surgery in which Fortiva Tissue Matrix will be used
• Have no contraindications to the test material (s)
• Able to provide informed consent
• Able to read, understand and complete study questionnaires
• Able and willing to return for scheduled study visits

Exclusion criteria

• <18 years of age
• American Society of Anesthesiologists (ASA) physical class of 4,5 or 6
• Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
• Hernia repairs involving active infection

Trial design

120 participants in 1 patient group

Fortiva Tissue Matrix

Treatment:

Device: Fortiva Tissue Matrix