LaryngectomyNCT07366281
Post-operative Use of New Adhesive After Total Laryngectomy
A study testing Provox Life Comfort Adhesive in people with Laryngectomy, run by Atos Medical AB at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy
- What is being tested?
- Provox Life Comfort Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesNetherlands
- Study dates
- 30 Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient undergoing total laryngectomy surgery
- 18 years or older
Who cannot join
- Unable to give informed consent prior to TL surgery
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Antoni van Leeuwenhoek, Netherlands Cancer Institute
Amsterdam, 1066 CX
Michiel W.M. van den Brekel, Prof. Dr., +31 512 25 50, m.vd.brekel@nki.nl
Michiel W.M. van den Brekel, Prof. Dr.
- Not yet recruiting
University Medical Center Groningen
Groningen
György Halmos, M.D., Ph.D., +31-50-3612540, g.b.halmos@umcg.nl
György Halmos, M.D., Ph.D.
- Recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
Francesco Missale, Dr., 043-3874594, francesco.missale@mumc.nl
Francesco Missale, Dr.
About this study
Official title: Post-operative Use of the New Adhesive After Total Laryngectomy
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:
Read more
- 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
- Being tested
- Provox Life Comfort Adhesive
- Keywords
- Adhesive baseplate, Tracheostoma care, Postoperative stoma management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provox Life Comfort AdhesiveDevice
The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.
| Study group | Role | What they receive |
|---|---|---|
| Exploratory post-operative use of Comfort Adhesive | Experimental | Participants will start using a newly developed adhesive called Provox Life Comfort Adhesive in the immediate post-operative period following total laryngectomy. Receives: Device: Provox Life Comfort Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Able to Use New Adhesive During Postoperative Period
Ability to use new adhesive continuously during the postoperative period, without discontinuation due to intolerance or complications related to the adhesive. Assessed through patient diary and investigator review.
Measured: From enrollment to the end of treatment at 30 days.
Secondary outcomes (12)
Number of Skin Reactions or Pain/Discomfort Assessed by Investigator and Patient
Presence of skin reactions under or around the adhesive and pain/discomfort, assessed by investigator and patient. Skin condition evaluated using the Skin Integrity Severity Assessment Scale (0 = Normal, 1 = Mild, 2 = Moderate, 3 = Severe) and investigator assessment of erythema, vesicles, maceration, skin tears, crusting, and edema. Includes reported discomfort (VAS 0-10).
Measured: From enrollment to the end of treatment at 30 days.
Performance: Adhesive Adhesion Performance: Score on 5-Point Adhesion Rating Scale
Ability of adhesive to remain attached during intended wear period, assessed on a 5-point scale of Adhesion Rating Scale, that ranges from "Adhesion of Adhesive is very bad " to "Adhesion of Adhesive is very good".
Measured: From enrollment to the end of treatment at 30 days.
Device Life Measured as Hours Adhesive Remains in Place
Hours adhesive remains in place before replacement.
Measured: From enrollment to the end of treatment at 30 days.
Performance: Adequacy of Adhesive Fit Around Stoma on a 5-Point Stoma Fit Scale
Investigator and patients assessment of adhesive fit around stoma, assessed on a 5-point Stoma Fit scale ranging from "Adhesive does not fit at all" to "Adhesive fits very well".
Measured: From enrollment to the end of treatment at 30 days.
Performance: Ease of Adhesive Application and Removal on 5-Point Ease Scale
Patient and investigator rating/assessment of how easy adhesive is to apply and remove, assessed on a 5-point scale ranging from "Very difficult" to "Very easy".
Measured: From enrollment to the end of treatment at 30 days.
Performance: Ability to Observe Area Underneath Adhesive
Whether skin under adhesive can be inspected without removal.
Measured: From enrollment to the end of treatment at 30 days.
Number of Participants for Whom Adhesive Was Successfully Applied Directly Over Sutures Without Complications
Feasibility of applying adhesive over sutures without complications.
Measured: From enrollment to the end of treatment at 30 days.
Number of Participants Able to Speak Using the Comfort Adhesive
Ability to speak while the Comfort Adhesive is in place will be assessed by both the patient and the investigator using a binary response (Yes/No). A "Yes" response indicates the participant is able to speak with a voice prosthesis while using the Comfort Adhesive. Higher frequency of "Yes" responses reflects a better outcome.
Measured: From enrollment to the end of treatment at 30 days.
Pulmonary rehabilitation: Average Hours of Heat and Moisture Exchanger Use per 24 Hours
Hours of heat and moisture exchanger use per 24 hours.
Measured: From enrollment to the end of treatment at 30 days.
Pulmonary rehabilitation: Interference With Sputum Clearance While Using Adhesive: Score on 4-Point Mucus Trapping Scale
Difficulty with sputum clearance while using the adhesive will be assessed by patient and investigator using a 4-point Mucus Trapping Scale ranging from "Mucus gets often trapped under the adhesive" to "Mucus never gets trapped under the adhesive".
Measured: From enrollment to the end of treatment at 30 days.
Use of Supplemental Oxygen During Postoperative Period
Need for supplemental oxygen will be assessed by investigator confirmation using a categorical response:
- Yes (used supplemental oxygen throughout)
- Yes, but weaned (used initially, then discontinued)
- No (did not use supplemental oxygen)
Measured: From enrollment to the end of treatment at 30 days.
Patient-Reported Comfort Level: Score on 5-Point Comfort Scale
Patient-reported comfort level using adhesive, assessed on a 5-point Comfort Scale ranging from "Very Uncomfortable" to "Very Comfortable."
Measured: From enrollment to the end of treatment at 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start30 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366281
- Sponsor's protocol ID
- PL_Adhesive
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Use of the New Adhesive After Total Laryngectomy
- ClinicalTrials.gov ID
- NCT07366281
- Acronym / sponsor ID
- PL_Adhesive
- Conditions
- Laryngectomy
- Keywords
- Adhesive baseplate, Tracheostoma care, Postoperative stoma management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Jan 2026 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exploratory post-operative use of Comfort Adhesive | Experimental | Device: Provox Life Comfort AdhesiveParticipants will start using a newly developed adhesive called Provox Life Comfort Adhesive in the immediate post-operative period following total laryngectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing total laryngectomy surgery
- 18 years or older
Key exclusion criteria (1 listed)
- Unable to give informed consent prior to TL surgery
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 |
|---|---|---|
| Provox Life Comfort AdhesiveThe new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients. | Device | Exploratory post-operative use of Comfort Adhesive |
Primary outcome
Proportion of Participants Able to Use New Adhesive During Postoperative Period
Time frame: From enrollment to the end of treatment at 30 days.
Ability to use new adhesive continuously during the postoperative period, without discontinuation due to intolerance or complications related to the adhesive. Assessed through patient diary and investigator review.
12 secondary outcomes
Number of Skin Reactions or Pain/Discomfort Assessed by Investigator and Patient
Time frame: From enrollment to the end of treatment at 30 days.
Performance: Adhesive Adhesion Performance: Score on 5-Point Adhesion Rating Scale
Time frame: From enrollment to the end of treatment at 30 days.
Device Life Measured as Hours Adhesive Remains in Place
Time frame: From enrollment to the end of treatment at 30 days.
Performance: Adequacy of Adhesive Fit Around Stoma on a 5-Point Stoma Fit Scale
Time frame: From enrollment to the end of treatment at 30 days.
Performance: Ease of Adhesive Application and Removal on 5-Point Ease Scale
Time frame: From enrollment to the end of treatment at 30 days.
Performance: Ability to Observe Area Underneath Adhesive
Time frame: From enrollment to the end of treatment at 30 days.
Number of Participants for Whom Adhesive Was Successfully Applied Directly Over Sutures Without Complications
Time frame: From enrollment to the end of treatment at 30 days.
Number of Participants Able to Speak Using the Comfort Adhesive
Time frame: From enrollment to the end of treatment at 30 days.
Pulmonary rehabilitation: Average Hours of Heat and Moisture Exchanger Use per 24 Hours
Time frame: From enrollment to the end of treatment at 30 days.
Pulmonary rehabilitation: Interference With Sputum Clearance While Using Adhesive: Score on 4-Point Mucus Trapping Scale
Time frame: From enrollment to the end of treatment at 30 days.
Use of Supplemental Oxygen During Postoperative Period
Time frame: From enrollment to the end of treatment at 30 days.
Patient-Reported Comfort Level: Score on 5-Point Comfort Scale
Time frame: From enrollment to the end of treatment at 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Antoni van Leeuwenhoek, Netherlands Cancer Institute
Amsterdam, Netherlands
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provox Life Comfort Adhesive in people with Laryngectomy, run by Atos Medical AB at 3 sites in Netherlands.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Able to Use New Adhesive During Postoperative Period (time frame: From enrollment to the end of treatment at 30 days.). 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 24 Sep 2026.