Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07369050
Eligibility Criteria:
Inclusion Criteria:
1. Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture
2. Using or ready for fit of indwelling voice prosthesis
3. No evidence of disease (NED) in head and neck
4. At least 6 months since cancer treatment
5. TEP tract length 4.5 to 12.5mm at time of enrollment\*
* The range reflects the available device sizes for the Provox® ActiValve® . Eligibility is determined by confirming that the patient is appropriately fitted with a VP within this size range, based on the site's standard clinical practice (e.g. appearance/fit and/or depth gauge).
Exclusion Criteria:
1. History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months)
2. History of recurrent VP extrusion (within last 12 months)
3. Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU)
4. History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months)
5. Active malignancy in head and neck and/or chest at the time of enrollment
6. Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment
7. Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons
8. Planned regular VP exchanges at outside facility within next 12 months
9. History of gastric pull-up reconstruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07369050
Study Brief:
Protocol Section:
NCT07369050