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NCT05094089 · ClinicalTrials.gov registry record

Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

A clinical trial of Hernia, Ventral and Hernia Incisional Ventral, sponsored by W.L.Gore & Associates.

Active
Registry status
320
Enrollment target
15
Study locations

NCT05094089: Active study of Hernia, Ventral and Hernia Incisional Ventral, sponsored by W.L.Gore & Associates.

NCT05094089 is a study of Hernia, Ventral and Hernia Incisional Ventral that is active but no longer recruiting, run by W.L.Gore & Associates. The registered enrollment target is 320 participants, above the 138-participant average among 7 other Hernia, Ventral trials with a reported enrollment target (132% higher). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05094089, a study of Hernia, Ventral and Hernia Incisional Ventral, is active but no longer recruiting, sponsored by W.L.Gore & Associates.

ACTIVE NOT RECRUITING
Registry status
320 participants
Enrollment target
15
Study locations

Study Summary

The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application. Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of 60 months.

Primary Outcome

Hernia Recurrence Treated Location

Interventions

  • DEVICE Hernia repair with mesh

Study Locations (15)

Other

  • Ospedale Civile di Baggiovara - Baggiovara
  • Vincenzo Monaldi Hospital - Naples
  • Sapienza Università di Roma - Roma
  • University Hospital Virgen Macarena - Department of General And Digestive Surgery - Seville
  • Hospital Quirón Salud-Sagrado Corazón - Seville
  • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham - Birmingham
  • Walsall Manor Hospital - Walsall

Georgia

  • Emory Saint Joseph's Hospital - Atlanta

Massachusetts

  • Tufts Medical Center - Boston

Michigan

  • Corewell Health - Grand Rapids

New Mexico

  • Lovelace Women's Hospital - Albuquerque

New York

  • Stony Brook University Hospital - Stony Brook

North Carolina

  • Novant Health New Hanover Regional Medical Center - Wilmington

South Carolina

  • Prisma Health Greenville Memorial Hospital - Greenville

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2023-02-24
Est. Completion 2030-07-31
W.L.Gore & Associates

53 total trials

What the registry record for NCT05094089 still lists

NCT05094089 is an observational study that tracks outcomes without assigning an intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 138-participant average among 7 other Hernia, Ventral trials with a reported enrollment target (132% higher).

The record links to 3 conditions, with Hernia, Ventral appearing as the primary indexed condition, and to 1 intervention - of which Hernia repair with mesh is the first listed.

NCT05094089 lists 15 locations in 9 states (Other, Georgia, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT05094089 about?

NCT05094089 is a clinical study titled "Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application". The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application. Patients with ventral / incisional hernia amena...

What is the current status of trial NCT05094089?

This trial is currently active not recruiting. The enrollment target is 320 participants. The study started on 2023-02-24. Estimated completion is 2030-07-31.

What conditions does trial NCT05094089 study?

This clinical trial studies the following conditions: Hernia, Ventral, Hernia Incisional Ventral, Hernia Incisional.

What interventions are being tested in trial NCT05094089?

The interventions under investigation include: Hernia repair with mesh (DEVICE).

Who is sponsoring clinical trial NCT05094089?

This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05094089 being conducted?

This trial has 15 study locations across Georgia, Massachusetts, Michigan, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05094089, the US trial registry maintained by the National Library of Medicine. NCT05094089 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.