Last reviewed · How we verify
NCT05079386
Clinical Feasibility of a New Voice Prosthesis
NA trial testing New Voice Prosthesis in Laryngectomy in 17 participants. Completed in 27 January 2023.
27 January 2023
Quick facts
| Lead sponsor | Atos Medical AB |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 17 |
| Start date | 7 January 2022 |
| Primary completion | 27 January 2023 |
| Estimated completion | 27 January 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- New Voice Prosthesis
Conditions studied
- Laryngectomy — all drugs for Laryngectomy →
Sponsor
Atos Medical AB
Who can join
18 and older, any sex, with Laryngectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05079386
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Laryngectomy
Currently open trials in the same condition.
- NCT06856863 — Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice · NA · recruiting
Other Atos Medical AB trials
Trials by the same sponsor.
- NCT07366281 — Post-operative Use of New Adhesive After Total Laryngectomy · NA · not yet recruiting
- NCT06084611 — Long Term Effects of Heat and Moisture Exchangers (HMEs) · NA · completed
- NCT04943731 — Day/Night Regimen With Provox Life Heat and Moisture Exchangers · NA · completed
- NCT05482815 — Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy · NA · unknown
- NCT04974801 — Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05079386 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Atos Medical AB
- Last refreshed: 13 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05079386.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing