APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned to be enrolled.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Male and female patients between 18 and 80 years.

- Diagnosed with permanent UVFP and insufficient glottal closure.

- A significant voice disorder as measured by perceptual rating (Grade ≥ 2 GRBAS Scale)
and Voice Handicap Index (VHI-30 score > 33).

- Ability to comprehend the full nature and purpose of the study, including possible
risks and side effects.

- Ability to co-operate with the Investigator and to comply with the requirements of the
entire study.

- Availability to volunteer for the entire study duration, willing to adhere to all
protocol requirements and willing and able to give informed consent for participation.

Exclusion Criteria:

- Any other significant disease or disorder which, in the opinion of the investigator,
may either put the participant at risk because of participation in the clinical
investigation may influence the result of the clinical investigation, or the
participant's ability to participate in the clinical investigation.

- Scheduled elective surgery or other procedures requiring general anaesthesia during
clinical investigation.

- Bilateral vocal fold paralysis.

- Had injection medialization laryngoplasty with the injectable still being within the
double length of the maximum resorption time frame as stated in their approval or as
supported by literature.

- Presence of structural vocal fold lesions such as polyp or nodules.

- Presence of oropharyngeal or laryngeal tumors.

- Patients with diagnosed severe obstructive sleep apnea (OSA).

- Status post total cordectomy.

- Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction).

- Status post tracheostomy

- Presence of acute systemic infection at time of screening or shortly before surgery.

- Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel
of trained speech therapists).

- Severe coagulopathy.

- Females who are pregnant, lactating or planning pregnancy are excluded from the
investigation.

- Patients with bil. Gr. III-IV hypertrophic tonsils.

- Diabetes mellitus with poor control and poor wound healing history.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/5/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

David Lott, M.D.

Open for enrollment

Contact information:

Samantha Poletti R.N.

(480) 574-1792

Poletti.Samantha@mayo.edu

More information

Publications

Publications are currently not available