Clinical trial NCT04315415: A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
Official title: A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Fold Palsy
Vocal Cord Paralysis
Vocal Cord Atrophy
Keywords: silk, vocal fold
Lead sponsor: Sofregen Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 14
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject enrolled will receive implantation of both Silk Voice and control material.
Primary purpose: BASIC_SCIENCE

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.

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);
  * 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.

Primary outcomes:
measure: Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
timeFrame: 6 month
measure: Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
timeFrame: 12 month
measure: Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
timeFrame: 24 month
Secondary outcomes:
measure: Number of patient and number of reported adverse events reported
timeFrame: 6 month
measure: Number of patient and number of reported adverse events reported
timeFrame: 12 month
measure: Number of patient and number of reported adverse events reported
timeFrame: 24 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
References: