A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

NCT04315415 | Completed DMC FDA Device

• 1 other identifier: SOF-003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Fold Palsy; Vocal Cord Paralysis; Vocal Cord Atrophy

Keywords

silk, vocal fold

Outcome Measures

Primary Outcomes (3)

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

  Tissue samples extracted at 6 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.

  6 month

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

  Tissue samples extracted at 12 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.

  12 month

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

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

  24 month

Secondary Outcomes (3)

• Number of patient and number of reported adverse events reported

  6 month

• Number of patient and number of reported adverse events reported

  12 month

• Number of patient and number of reported adverse events reported

  24 month

Study Arms (3)

6 month explant

OTHER

Silk Voice and control material are implanted. The implanted material is explanted at 6 months.

Device: Silk Voice

12 month explant

OTHER

Silk Voice and control material are implanted. The implanted material is explanted at 12 months.

Device: Silk Voice

24 month explant

OTHER

Silk Voice and control material are implanted. The implanted material is explanted at 24 months.

Device: Silk Voice

Interventions

Silk Voice DEVICE

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

12 month explant; 24 month explant; 6 month explant

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);
• the presence of cancerous or pre-cancerous lesions in the area to be treated;
• the presence of moderate or severe abnormal rating for firmness or detection of any abnormal structure at the site of injection, such as a scar or lump;
• the current use of immunosuppressive therapy;
• who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites
• a history of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis or scleroderma;
• participation in any interventional clinical research study within 30 days prior to randomization;

Sponsors & Collaborators

• Sofregen Medical, Inc.: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject enrolled will receive implantation of both Silk Voice and control material.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 19, 2020
• Study Start: January 15, 2020
• Primary Completion: February 17, 2022
• Study Completion: April 18, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)