NCT05762497 is a NA clinical trial of Moldable adhesive in Laryngectomy; Status, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Who is sponsoring NCT05762497?

NCT05762497 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT05762497?

Interventions in NCT05762497: Moldable adhesive.

What condition does NCT05762497 study?

NCT05762497 studies Laryngectomy; Status.

Is NCT05762497 still recruiting?

NCT05762497 is currently completed. Last updated 9 March 2023.

Last reviewed 2023-03-09 · How we verify

NCT05762497

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Feasibility Study of Peristomal Adhesives

Completed NA Last updated 9 March 2023

What this trial tests

NA trial testing Moldable adhesive in Laryngectomy; Status in 10 participants. Completed in 27 December 2022.

Timeline

1 July 2022

Primary endpoint
1 September 2022

27 December 2022

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 July 2022
Primary completion	1 September 2022
Estimated completion	27 December 2022
Sites	1 location across Italy

Drugs / interventions tested

Moldable adhesive

Conditions studied

Laryngectomy; Status — all drugs for Laryngectomy; Status →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, any sex, with Laryngectomy; Status. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Loss of voice is one of the greater consequences of total laryngectomy. The voice prosthesis allows the patients to speak again in a very short time but forces them to use one hand when speaking. In order to reduce this discomfort and to allow "hands-free" speaking, an Automatic Speaking Valve (ASV) has been designed which is positioned on a peristomal adhesive. Peristomal adhesives, however, tend to detach under the influence of mucus, cough, or phonatory pressure. Consequently, the current regular use of the automatic speaking valve in laryngectomees is very low. As a possible solution, Atos Medical AB has developed a moldable peristomal adhesive made of a thermoplastic elastomer, which becomes transparent and moldable when heated and facilitates precise contouring in situ. As the material cools, it loses its malleability but retains the integrity of the molded shape. The expectation was that the moldable adhesive would provide a better individual fit and therefore longer fixation (especially when using the ASV). To study the feasibility of this device, 10 total laryngectomized patients were asked to use the new moldable peristomal adhesive for two weeks in conjunction with their normal daily routine for adhesive application and removal, and speech rehabilitation.

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:

Other recruiting trials for Laryngectomy; Status

Currently open trials in the same condition.

NCT06077643 — Workshops and Exchange Groups for Laryngectomized Patients · recruiting
NCT05489965 — Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis) · recruiting

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05762497 (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 Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Last refreshed: 9 March 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/NCT05762497.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing