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NCT07149116
Intratracheal Tracheostomy Sealing - A Clinical Feasibility Study
NA trial testing Tracheostomy sealing in Tracheostomy Complications in 10 participants. Completed in 8 March 2025.
8 December 2024
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 20 January 2023 |
| Primary completion | 8 December 2024 |
| Estimated completion | 8 March 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Tracheostomy sealing
Conditions studied
- Tracheostomy Complications — all drugs for Tracheostomy Complications →
Sponsor
University of Aarhus
Who can join
18 and older, any sex, with Tracheostomy Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical feasibility of intratracheal tracheostomy sealing using a novel sealing disc prototype.
Kraghede RE, Nielsen LW, Christiansen KJ, Dyrskog S, et al · · 2026 · PMID 41872384 · DOI 10.1038/s41598-026-41209-8
Verify or expand the search:
- PubMed search for NCT07149116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Tracheostomy Complications
Currently open trials in the same condition.
- NCT07121517 — "Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or · recruiting
- NCT06906263 — Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy. · recruiting
Other University of Aarhus trials
Trials by the same sponsor.
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- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
- NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
- NCT07451028 — Effect of an Oral Neuromuscular Training Device on Dysphagia · NA · not yet recruiting
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 NCT07149116 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 29 August 2025
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/NCT07149116.
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