Laryngectomy; StatusNCT05762497
Pilot Feasibility Study of Peristomal Adhesives
A study testing Moldable adhesive in people with Laryngectomy; Status, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy; Status
- What is being tested?
- Moldable adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 27 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have undergone total laryngectomy
- Over the age of 18
- voice prosthesis user
- Experience in the use of adhesive and HMEs
- At least 3 months after total laryngectomy
- At least 6 months after the end of adjuvant radiotherapy
- Signature of the informed consent
Who cannot join
- Medical issues that prevent the use of HMEs and/or adhesives
- Recurrent or metastatic active disease
- Reduced mobility of the arms and/or hands
- Inability to understand the information and/or to provide informed consent
- Insufficient cognitive ability to handle HME or moldable adhesive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Feasibility Study of a Moldable Peristomal Adhesive for Pulmonary and Speech Rehabilitation After Total Laryngectomy
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.
Read more
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.
- Conditions
- Laryngectomy; Status
- Being tested
- Moldable adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moldable adhesiveOther
Patients were provided with the new adhesives and a short questionnaire on current ASV use. After a week, they were contacted by telephone to verify any doubts/problems. At the end of the two weeks, the patient was again administered a questionnaire to evaluate the new moldable adhesive (while using the ASV).
| Study group | Role | What they receive |
|---|---|---|
| Laryngectomized patients | Experimental | Not described Receives: Other: Moldable adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation about product performance
Adhesive lifetime during hands-free speech use [hours]
Measured: 2 weeks
Investigation about product performance
Use of hands-free speech [days/week]
Measured: 2 weeks
Investigation about product performance
Duration of hands-free speech [hours/day]
Measured: 2 weeks
Secondary outcomes (3)
Parameters were expected to influence product performance and patient preference
Satisfaction (scored on a 5-point Likert scale)
Measured: 2 weeks
Parameters were expected to influence product performance and patient preference
Adhesives fit (scored on a 5-point Likert scale)
Measured: 2 weeks
Parameters were expected to influence product performance and patient preference
Adhesives usability (scored on a 5-point Likert scale),
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Jul 2022
- Primary completion1 Sep 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngectomy; StatusStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parrilla Claudio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Claudio Parrilla, MD, PhD, Principal investigator, Fondazione Policlinico Gemelli - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762497
- Sponsor's protocol ID
- 4650
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of a Moldable Peristomal Adhesive for Pulmonary and Speech Rehabilitation After Total Laryngectomy
- ClinicalTrials.gov ID
- NCT05762497
- Acronym / sponsor ID
- 4650
- Conditions
- Laryngectomy; Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngectomized patients | Experimental | Other: Moldable adhesive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have undergone total laryngectomy
- Over the age of 18
- voice prosthesis user
- Experience in the use of adhesive and HMEs
- At least 3 months after total laryngectomy
Key exclusion criteria (5 listed)
- Medical issues that prevent the use of HMEs and/or adhesives
- Recurrent or metastatic active disease
- Reduced mobility of the arms and/or hands
- Inability to understand the information and/or to provide informed consent
- Insufficient cognitive ability to handle HME or moldable adhesive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moldable adhesivePatients were provided with the new adhesives and a short questionnaire on current ASV use. After a week, they were contacted by telephone to verify any doubts/problems. At the end of the two weeks, the patient was again administered a questionnaire to evaluate the new moldable adhesive (while using the ASV). | Other | Laryngectomized patients |
Primary outcome
Investigation about product performance
Time frame: 2 weeks
Adhesive lifetime during hands-free speech use [hours]
Investigation about product performance
Time frame: 2 weeks
Use of hands-free speech [days/week]
Investigation about product performance
Time frame: 2 weeks
Duration of hands-free speech [hours/day]
3 secondary outcomes
Parameters were expected to influence product performance and patient preference
Time frame: 2 weeks
Parameters were expected to influence product performance and patient preference
Time frame: 2 weeks
Parameters were expected to influence product performance and patient preference
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Laryngectomy; Status
RecruitingObservational study
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
Speech Disorders, Speech Dysfunction
RecruitingObservational study
Workshops and Exchange Groups for Laryngectomized Patients
Laryngectomy; Status, Laryngeal Cancer
RecruitingPhase 2
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Parrilla, MD, PhD principal investigator
Fondazione Policlinico Gemelli - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moldable adhesive in people with Laryngectomy; Status, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation about product performance (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.