A Prospective Study of Fortiva in Hernia Repair

Incisional Hernia Clinical Trial

Official title:

A Prospective Study of Fortiva in Hernia Repair

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06101979
• Other study ID #: RTI-2022-01
• Status: Enrolling by invitation
• Start date: November 15, 2023
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Hernia

Intervention

Device:
• Fortiva Tissue Matrix
Acellular Dermal Matrix used in hernia surgery

Locations

Country	Name	City	State
United Kingdom	James Paget University Hospital	Great Yarmouth

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of adverse events		6 weeks, 6 months, 12 months and 24 months
Secondary	Patient satisfaction	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	6 weeks, 6 months, 12 months and 24 months
Secondary	Pain measured using the visual analog scale for pain	Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain	6 weeks, 6 months, 12 months and 24 months
Secondary	Implant failure	Partial or total removal of Fortiva Tissue Matrix	6 weeks, 6 months, 12 months and 24 months
Secondary	Hernia recurrence	Hernia recurrence requiring surgical reintervention	12 months