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Post-operative Use of New Adhesive After Total Laryngectomy

NCT07366281 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-07-14

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the feasibility, safety, and performance of the new adhesive when used in the immediate post-operative period after total laryngectomy.

The main question it aims to answer is:

\- Is the adhesive feasible and safe to use during the early post-operative phase?

This is a single-arm feasibility study with historical controls, so there is no concurrent comparison group. Researchers will compare outcomes to historical data from standard adhesive use to assess improvements in tolerance and skin condition.

Participants will:

* Use the adhesive as part of their standard post-laryngectomy care.
* Complete patient-reported outcome questionnaires (e.g., comfort, skin assessment, satisfaction).
* Allow investigators to record observations in diaries and patient charts.
* Participate in routine clinical assessments during hospitalization and at end of study (approximately 30 days post-surgery).

Conditions

  • Laryngectomy

Interventions

DEVICE

Provox Life Comfort Adhesive

The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.

Sponsors & Collaborators

  • Atos Medical AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366281 on ClinicalTrials.gov