CompletedNot Applicable

T-GENVIH-003 LTFU (Long Term Follow Up) Study

United States8 participantsStarted 2023-09-12

Plain-language summary

The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.

Who can participate

Age range22 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient was a subject in the T-GENVIH-002 study and underwent minimally invasive (i.e., laparoscopic or robotic) abdominal wall reconstruction for a primary hernia using Integra® Gentrix® Surgical Matrix. * Subject has participated in the informed consent process and signed a study-specific informed consent document. * Subject is fluent in US English or US Spanish language. * Subject is willing to complete an e-consent and phone or in-office visit. Exclusion Criteria: * Not applicable.

What they're measuring

Number of Participants With Clinically Confirmed Recurrence

Timeframe: Through study completion, an average of 4 months.

Trial details

NCT IDNCT06034652

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-01-19

Results submitted2024-05-29

View on ClinicalTrials.gov More Hernia trials