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Intratracheal Tracheostomy Sealing - A Clinical Feasibility Study

NCT07149116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-29

No results posted yet for this study

Summary

The purpose of this study is to investigate a new treatment method for tracheostomies - the term for the opening you have in your neck.

The treatment method seals the stoma tract from within the trachea. The aim is to improve lung function and voice quality, as well as to promote wound healing.

Study procedure: A silicone sealing device will be inserted into the stoma tract. This may cause temporary discomfort around the site and may induce some coughing. You will then undergo a pulmonary function test - also known as a spirometry test.

For the following 7 days, the sealing device will remain in the stoma tract and provide an airtight seal. You will be examined daily with spirometry, and the healing of the stoma tract will be closely monitored. A member of the research team will be present with you around the clock to ensure that the device remains correctly positioned. This is a safety precaution in the unlikely event that the sealing device dislocates into the airway.

After 7 days, the sealing device will be removed through the nearly healed stoma tract simply by pulling it out. This may again cause slight irritation or coughing.

Conditions

  • Tracheostomy Complications

Interventions

DEVICE

Tracheostomy sealing

A non-classified silicone-based prototype device designed to temporarily seal the tracheostomy tract from within the airway for up to 7 days after decannulation.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-12-08
Completion
2025-03-08

Countries

  • Denmark

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 NCT07149116 on ClinicalTrials.gov