A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

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.

Study Overview

• Status: Completed
• Conditions: Vocal Cord Paralysis; Vocal Cord Atrophy; Vocal Fold Palsy
• Intervention / Treatment: Device: Silk Voice

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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);
  • 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;
  • subjects not likely to stay in the study for up to 13 months because of other commitments, concomitant conditions, or past history;
  • subjects anticipated to be unreliable; or subjects who have a concomitant condition that might confuse or confound study treatments or assessments;
  • Subject with skin conditions (discoloration, textured, scarring, etc.) in postauricular region that may complicate study evaluation metrics
  • Subjects that are not considered to be an appropriate candidate at the discretion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 6 month explant; Silk Voice and control material are implanted. The implanted material is explanted at 6 months.	Device: Silk Voice; Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)
Other: 12 month explant; Silk Voice and control material are implanted. The implanted material is explanted at 12 months.	Device: Silk Voice; Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)
Other: 24 month explant; Silk Voice and control material are implanted. The implanted material is explanted at 24 months.	Device: Silk Voice; Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient and number of reported adverse events reported	Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated.	6 month
Number of patient and number of reported adverse events reported	Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated.	12 month
Number of patient and number of reported adverse events reported	Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated.	24 month

Collaborators and Investigators

• Sponsor: Sofregen Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): April 18, 2022

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: silk, vocal fold
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis
• Other Study ID Numbers: SOF-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No