194 | Chapter 8 Material and methods This is a prospective phase I clinical feasibility study performed at the Netherlands Cancer Institute (NKI-AvL) at the department Head-and-Neck Oncology and Surgery. The study was approved by their Medical Ethical Committee of the NKI-AvL (NL76694.031.21), and registered in Clinicaltrials.gov (NCT05079386). All participants signed informed consent before participating in this study. Participants Seventeen laryngectomized patients, >18 years, and initial baseline users of Provox ActiValve Light or Provox Vega (Atos Medical AB, Hörby, Sweden) (length 4, 6, 8, 10, 12.5, all 22.5 French diameter) were included in this study. Participants with current TEP problems, active recurrent or metastatic disease or unable to give informed consent were excluded. Procedure and data collection Between January 2022 until March 2022, patients who met the inclusion criteria were contacted for participation by telephone or during regular hospital visits. The study consisted of a short- and long-term period assessment (see Figure 1). User acceptance was evaluated during an initial two-week period, with the option to participate in a long-term observation period of up to twelve months. It is expected that two weeks is long enough to evaluate short-term acceptance and short enough to replace the PVHP if the patient is not satisfied. The PVHP was replaced with their regular VP at the end of the study. Acceptance was re-evaluated after ending of the study. Design of the PVHP The PVHP is an indwelling voice prosthesis with an outer diameter of 22.5 French. The housing and valve hinge is molded in transparent silicone rubber, whereas the valve flap and valve seat are made of fluoroplastic, similar to the ActiValve. At the esophageal end of the shaft sits a valve unit consisting of a valve seat, hinge and valve flap (figure 2). Use of the PVHP After cleaning the PVHP in the morning, participants need to apply lubricant by putting a drop on a cleaning brush and rotating the brush in the VP. The lubricant is needed because of the stickiness of the fluoroplastic. The use of lubricant prevents the valve flap from getting stuck, which causes blockage of speech. This is also used by ActiValve-users and has been on the market since 2003 when the ActiValve was released. The lubricant is a medical grade silicone oil. This one drop should be enough to avoid excessive stickiness but can be reapplied if needed13, 14.
RkJQdWJsaXNoZXIy MTk4NDMw