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A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

NCT04315415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Silk Voice

Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)

Sponsors & Collaborators

  • Sofregen Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2022-02-17
Completion
2022-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315415 on ClinicalTrials.gov