NCT06263985

Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

Prospective Analysis of Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Michigan Institution of Women's Health PC · Academic / Other
• Sex: Female
• Age: 21 Years – 89 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are: * Is the leading edge of the prolapse above the hymen * Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.

Detailed description

This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis™ Dermis biologic mesh. They will be followed for a period of 3 years. A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy. Clinical examination including vaginal wall retraction with or without pelvic ultrasound, POP-Q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Axis Dermis biologic mesh repair for pelvic organ prolapse	Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh.

Timeline

• Start date: 2021-11-02
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2024-02-16
• Last updated: 2024-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study