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NCT06710795 · ClinicalTrials.gov registry record · NA
AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
A NA study of Ventral Hernia, sponsored by Medtronic - MITG.
- Recruiting
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 3
- Study locations
NCT06710795: Recruiting NA study of Ventral Hernia, sponsored by Medtronic - MITG.
NCT06710795 is a NA study of Ventral Hernia that is actively recruiting participants, run by Medtronic - MITG. The registered enrollment target is 110 participants, below the 137-participant average among 18 other Ventral Hernia trials with a reported enrollment target (20% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06710795, a NA study of Ventral Hernia, is actively recruiting participants, sponsored by Medtronic - MITG.
- RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 3
- Study locations
Study Summary
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study. The purpose of this study is to evaluate the performance and safety of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures.
Primary Outcome
The Phase 1 primary endpoint is the incidence of Surgical Site Occurrence (SSO) within 3 months following the use of the MaxTack™ Motorized Fixation Device for fixation in ventral hernia repair procedures. SSOs are considered Adverse Events (AEs) related to the study device, mesh, and/or study procedure and defined as Seroma, Hematoma, Surgical Site Infection (SSI), and bleeding at the tack implantation site. Note: Non-symptomatic seromas requiring no medical or surgical treatment are not repor
Conditions Studied
Interventions
- DEVICE MaxTack™ Motorized Fixation Device
Study Locations (3)
Ohio
- Cleveland Clinic - Ohio - Cleveland
- The Ohio State University - Columbus
Florida
- Cleveland Clinic - Weston Hospital - Weston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2027-02-15 |
| Phase | NA |
What NCT06710795 shows while recruiting
NCT06710795 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 137-participant average among 18 other Ventral Hernia trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Ventral Hernia appearing as the primary indexed condition, and to 1 intervention - of which MaxTack™ Motorized Fixation Device is the first listed.
NCT06710795 reports a single indexed study location in Ohio, Florida.
Frequently Asked Questions
What is clinical trial NCT06710795 about?
NCT06710795 is a clinical study titled "AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair". Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study. The purpose of this study is to evaluate the performance and safety of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic m...
What is the current status of trial NCT06710795?
This trial is currently recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2024-11-26. Estimated completion is 2027-02-15.
What conditions does trial NCT06710795 study?
This clinical trial studies the following conditions: Ventral Hernia.
What interventions are being tested in trial NCT06710795?
The interventions under investigation include: MaxTack™ Motorized Fixation Device (DEVICE).
Who is sponsoring clinical trial NCT06710795?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06710795 being conducted?
This trial has 3 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ventral Hernia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06710795's enrollment target sits among peer trials
110 11th of 18 higher than 8 of 18 other Ventral Hernia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ventral 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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Robotic Versus Open Ventral Hernia Repair
RECRUITING · NA
-
Clinical Investigation of the da Vinci Surgical System
ACTIVE NOT RECRUITING · NA
-
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
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-
Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
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-
CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs
ACTIVE NOT RECRUITING · NA
-
Mesh Type in Ventral Hernia Repair
COMPLETED · NA
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