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Clinical Feasibility of a new adhesive base plate (placeholder for stoma appliances) for rehabilitation after total laryngectomy

Clinical Feasibility of a new adhesive base plate (placeholder for stoma appliances) for rehabilitation after total laryngectomy - Feasibility of new tracheostoma baseplate

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34698
Enrollment
50
Registered
2010-04-15
Start date
2010-05-17
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

laryngectomy removal of larynx

Interventions

Application of an adhesive base plate to the peristomal skin.

Sponsors

Atos Medical
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: laryngectomy voice prosthesis user HME user

Exclusion criteria

Exclusion criteria: skin problems tracheostoma, allergy to adhesive medical problems prohibiting HME use

Design outcomes

Primary

MeasureTime frame
Patient preference

Secondary

MeasureTime frame
Device life of the adhesive Patient satisfaction Voice and Speech (perceptual evaluation, maximum phonation time, phrasing) Ease of application

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)