NCT06710795

AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair

AFFIX: Evaluation of the performAnce and saFety of the MaxTack™ Motorized FIXation Device in Subjects Undergoing Repair of Ventral Hernia by Minimally Invasive Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures. Subjects will be followed in the short term (1 and 3 months) and long term (12 months) to evaluate safety and performance of the device. The study is being conducted in two phases. Phase 1 will enroll approximately 33 subjects at up to 3 sites in the United States. Based on regulatory needs, Phase 2 may enroll additional subjects at approximately 10 US sites, for a total of up to 110 subjects across both phases.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	MaxTack™ Motorized Fixation Device	All subjects enrolled will receive the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair

Timeline

• Start date: 2025-06-16
• Primary completion: 2026-03-23
• Completion: 2027-05-07
• First posted: 2024-11-29
• Last updated: 2026-04-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study