A Prospective Study of Fortiva in Hernia Repair

• Sponsor: RTI Surgical (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06101979
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 49
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ventral Hernia; Incisional Hernia; Abdominal Wall Reconstruction	Device: Fortiva Tissue Matrix

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study of Fortiva in Hernia Repair
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2027
• Anticipated Study Completion Date: Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Fortiva Tissue Matrix	Device: Fortiva Tissue Matrix; Acellular Dermal Matrix used in hernia surgery

Outcome Measures

Primary Outcome Measures

1. Type of adverse events [6 weeks, 6 months, 12 months and 24 months]

Secondary Outcome Measures

1. Patient satisfaction [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 [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 [6 weeks, 6 months, 12 months and 24 months]

   Partial or total removal of Fortiva Tissue Matrix

4. Hernia recurrence [12 months]

   Hernia recurrence requiring surgical reintervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James Paget University Hospital	Great Yarmouth		United Kingdom

Sponsors and Collaborators

• RTI Surgical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RTI Surgical
• ClinicalTrials.gov Identifier: NCT06101979
• Other Study ID Numbers: RTI-2022-01
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hernia; Hernia, Ventral; Incisional Hernia

Study Results

No Results Posted as of Oct 27, 2023