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Enrolling by Invitation

NCT Number: NCT06101979

A Prospective Study of Fortiva in Hernia Repair

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.

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Key information

Conditions

Ventral Hernia Abdominal Wall Reconstruction Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

James Paget University Hospital

Great Yarmouth, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortiva Tissue Matrix

Device

Acellular Dermal Matrix used in hernia surgery

Primary outcomes

  1. Type of adverse events

    Time frame: 6 weeks, 6 months, 12 months and 24 months

Secondary outcomes

  1. Patient satisfaction

    Time frame: 6 weeks, 6 months, 12 months and 24 months

    SF-36 questionnaire has 8 multi-item scales with a higher score representing better health status. Each domain has a score range of 0-100

  2. Pain measured using the visual analog scale for pain

    Time frame: 6 weeks, 6 months, 12 months and 24 months

    Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain

  3. Implant failure

    Time frame: 6 weeks, 6 months, 12 months and 24 months

    Partial or total removal of Fortiva Tissue Matrix

  4. Hernia recurrence

    Time frame: 12 months

    Hernia recurrence requiring surgical reintervention

Sponsors and collaborators

Lead sponsor

RTI Surgical

Industry

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2023
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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