NCT04315415

A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sofregen Medical, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary study goal is to evaluate the histological characteristic of Silk Voice to evaluate the potential for Silk Voice to deliver long-term results to patients.

Detailed description

The primary study goal is to evaluate the histological characteristic of Silk Voice at a surrogate implantation site to evaluate the potential for Silk Voice to deliver long-term results to patients. Information obtained from this study will help clinician determine Silk Voice's treatment duration and whether Silk Voice is appropriate for their patient.

Conditions

• Vocal Fold Palsy
• Vocal Cord Paralysis
• Vocal Cord Atrophy

Interventions

Type	Name	Description
DEVICE	Silk Voice	Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-02-17
• Completion: 2022-04-18
• First posted: 2020-03-19
• Last updated: 2022-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study