A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid

NCT ID: NCT04315415

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-04-18

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.

Conditions

Vocal Fold Palsy; Vocal Cord Paralysis; Vocal Cord Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

6 month explant

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

Group Type: OTHER

Silk Voice

Intervention Type: DEVICE

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

12 month explant

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

Group Type: OTHER

Silk Voice

Intervention Type: DEVICE

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

24 month explant

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

Group Type: OTHER

Silk Voice

Intervention Type: DEVICE

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

Interventions

Silk Voice

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

Intervention Type: DEVICE

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

• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sofregen Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Other Identifiers

SOF-003

Identifier Type: -

Identifier Source: org_study_id