Vocal Fold PalsyNCT04315415
A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
A study testing Silk Voice in people with Vocal Fold Palsy and Vocal Cord Paralysis, run by Sofregen Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vocal Fold Palsy, Vocal Cord Paralysis, Vocal Cord Atrophy
- What is being tested?
- Silk Voice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 18 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Silk Voice
- Keywords
- silk, vocal fold
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk VoiceDevice
Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)
| Study group | Role | What they receive |
|---|---|---|
| 6 month explant | Other | Silk Voice and control material are implanted. The implanted material is explanted at 6 months. Receives: Device: Silk Voice |
| 12 month explant | Other | Silk Voice and control material are implanted. The implanted material is explanted at 12 months. Receives: Device: Silk Voice |
| 24 month explant | Other | Silk Voice and control material are implanted. The implanted material is explanted at 24 months. Receives: Device: Silk Voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 month
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start15 Jan 2020
- Primary completion17 Feb 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject enrolled will receive implantation of both Silk Voice and control material.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofregen Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315415
- Sponsor's protocol ID
- SOF-003
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT04315415
- Acronym / sponsor ID
- SOF-003
- Conditions
- Vocal Fold Palsy, Vocal Cord Paralysis, Vocal Cord Atrophy
- Keywords
- silk, vocal fold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sofregen Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each subject enrolled will receive implantation of both Silk Voice and control material.
| Arm | Type | Receives |
|---|---|---|
| 6 month explant | Other | Device: Silk VoiceSilk Voice and control material are implanted. The implanted material is explanted at 6 months. |
| 12 month explant | Other | Device: Silk VoiceSilk Voice and control material are implanted. The implanted material is explanted at 12 months. |
| 24 month explant | Other | Device: Silk VoiceSilk Voice and control material are implanted. The implanted material is explanted at 24 months. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be eligible for enrollment, the Subject must meet the following:
Key exclusion criteria (20 listed)
- Patients will not enroll in the study if they meet any of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk VoiceSilk Voice comprised of silk protein and cross-linked hyaluronic acid (HA) | Device | 12 month explant, 24 month explant, 6 month explant |
Primary outcome
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Time frame: 6 month
Tissue samples extracted at 6 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation.
Time frame: 12 month
Tissue samples extracted at 12 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed.
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.
3 secondary outcomes
Number of patient and number of reported adverse events reported
Time frame: 6 month
Number of patient and number of reported adverse events reported
Time frame: 12 month
Number of patient and number of reported adverse events reported
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silk Voice in people with Vocal Fold Palsy and Vocal Cord Paralysis, run by Sofregen Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation. (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.