An interventional study of ENTegral Artificial Larynx implant in Total Laryngectomy, sponsored by ProTiP Medical. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by ProTiP Medical · Not applicable, Interventional, and Treatment
The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.
ProTiP Medical is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ENTegral Artificial Larynx implantation
Device: ENTegral Artificial Larynx implant
Feasibility of device implant procedure
Number of patients with adverse event associated with device implantation procedure
Time frame: 1 year
Quality of life
Quality of life using EORTC QLQ-C30 and QLQ-H\&N25 questionnaires
Time frame: 1, 3, 6 months and 1 year
Number of patients with adverse events
Number of patients with adverse events will be assessed at each follow-up during the 1 year patient follow-up
Time frame: 1 year
Dyspnea evolution
Dyspnea evaluation using the Heyse-Moore scale at 1, 2, 3, 6, 9 months and 1 year
Time frame: 1,2,3,6,9 months and 1 year
Phonation evolution
Patient phonation (able to talk and be understood, whispered voice) will be assessed at 1, 2, 3, 6, 9 months and 1 year
Time frame: 1,2,3,6,9 months and 1 year
Implant use
Implant use (manual closure of the tracheostomy orifice) duration will be assessed at 1, 2, 3, 6, 9 months and 1 year, allowing eventually to surgically close the orifice
Time frame: 1,2,3,6,9 months and 1 year
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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ProTiP Medical