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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: Active NA study of Hernia and Hernia, Ventral, sponsored by Medtronic - MITG.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Occurrence of clinical hernia recurrence evaluated by physical examination and confirmed, if deemed necessary by a study investigator, following site standard of care medical imaging for hernia evaluation.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2030-10-01 |
| Phase | NA |
What the registry record for NCT06449378 still lists
NCT06449378 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 188-participant average among 11 other Hernia trials with a reported enrollment target (13% lower).
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 lists 13 locations in 6 states (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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Where NCT06449378's enrollment target sits among peer trials
163 4th of 11 higher than 8 of 11 other Hernia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hernia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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