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NCT06449378 · ClinicalTrials.gov registry record · NA

Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia

A NA study of Hernia and Hernia, Ventral, sponsored by Medtronic - MITG.

Active
Registry status
NA
Development phase
163
Enrollment target
13
Study locations

NCT06449378 is a NA study of Hernia and Hernia, Ventral that is active but no longer recruiting, run by Medtronic - MITG. The registered enrollment target is 163 participants, below the 188-participant average among 11 other Hernia trials with a reported enrollment target (13% lower). The trial reports 13 study locations across 6 states.

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The verdict

NCT06449378, a NA study of Hernia and Hernia, Ventral, is active but no longer recruiting, sponsored by Medtronic - MITG.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
163 participants
Enrollment target
13
Study locations

Study Summary

The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall soft tissues in procedures involving open extraperitoneal ventral hernia repair, in clean (US); and clean and clean-contaminated (Europe) surgical fields (Centers for Disease Control and Prevention (CDC) Classification I and II. Data from this study will primarily be used to support market approval and European post-market clinical follow-up needs. Secondarily, data will be used for product marketing, future product development, and to support market release and maintenance in global geographies.

Interventions

  • DEVICE Transorb™ Self-Gripping Resorbable Mesh

Study Locations (13)

Other

  • UZ Leuven, campus Gasthuisberg - Leuven
  • APHP Hospital Louis Mourier - Colombes
  • Centre Hospitalier Universitaire de Lille - Lille
  • Hospices Civils de Lyon - Lyon
  • Centre Hospitalier Universitaire de Reims - Reims
  • Hôpital Charles Nicolle Centre Hospitalier Universitaire de Rouen - Rouen
  • Hôpitaux Universitaires de Strasbourg - Strasbourg

Ohio

  • Cleveland Clinic Foundation - Cleveland
  • The Ohio State University - Columbus

Illinois

  • Northwestern University - Evanston

Kentucky

  • University of Kentucky - Lexington

North Carolina

  • Novant Health New Hanover Regional Medical Center - Wilmington

Virginia

  • TPMG General Surgery and Hernia Center - Newport News

Trial Details

FieldValue
Enrollment Target 163 participants
Start Date 2024-07-02
Est. Completion 2030-10-01
Phase NA

Sponsor

Medtronic - MITG

119 total trials

What the Registry Record Tells You About NCT06449378

The ClinicalTrials.gov registry entry for NCT06449378 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 188-participant average among 11 other Hernia trials with a reported enrollment target (13% lower). The listed sponsor is Medtronic - MITG, which has 119 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Hernia appearing as the primary indexed condition, and to 1 intervention - of which Transorb™ Self-Gripping Resorbable Mesh is the first listed.

NCT06449378 reports 13 study locations spanning 6 distinct geographic areas - top geographies include Other, Ohio, Illinois.

Frequently Asked Questions

What is clinical trial NCT06449378 about?

NCT06449378 is a clinical study titled "Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia". The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall soft tissues in procedures involving open extraperitoneal ventral hernia ...

What is the current status of trial NCT06449378?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 163 participants. The study started on 2024-07-02. Estimated completion is 2030-10-01.

What conditions does trial NCT06449378 study?

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

What interventions are being tested in trial NCT06449378?

The interventions under investigation include: Transorb™ Self-Gripping Resorbable Mesh (DEVICE).

Who is sponsoring clinical trial NCT06449378?

This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06449378 being conducted?

This trial has 13 study locations across Illinois, Kentucky, North Carolina, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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