A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

Sofregen Medical, Inc.1 site in 1 country14 target enrollmentJanuary 15, 2020

ConditionsVocal Fold Palsy Vocal Cord Paralysis Vocal Cord Atrophy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vocal Fold Palsy
Sponsor: Sofregen Medical, Inc.
Enrollment: 14
Locations: 1
Primary Endpoint: Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 15, 2020

End Date

April 18, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sofregen Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•To be eligible for enrollment, the Subject must meet the following:
•males or non-pregnant, non-breastfeeding females 21 to 65 years old who are willing to comply with the requirements of the study, including sequential photography, periodic check-ins and retrieval of implanted materials;
•women of childbearing potential using an acceptable form of birth control during the study period and willingness to take a urine pregnancy test at baseline and at the biopsy date;
•sign the Informed Consent form and the Authorization for Use and Release HIPAA form prior to any study-related procedures being performed.
•read and understand English

Exclusion Criteria

•Patients will not enroll in the study if they meet any of the following exclusion criteria:
•a history of allergy or hypersensitivity to injectable hyaluronic acid gel;
•a history of allergy or hypersensitivity to silk;
•a history of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
•history of allergies of lidocaine
•a history of susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders.
•currently have a hyaluronic acid device implanted
•the presence of any contraindication to the implant procedures, including use of platelet inhibiting agents or other anticoagulant, in a relevant period before study entry (per the treating investigator's judgment);
•the presence of any condition, which in the opinion of the investigator, that makes the subject unable to complete the study per protocol;
•the presence of known allergies or hypersensitivity reactions to local topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject);

Outcomes

Primary Outcomes

Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.

Time Frame: 24 month

Tissue samples extracted at 24 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.