Larynx CancerNCT01045057
Clinical Feasibility of New Tracheoesophageal Puncture Set
A study testing Puncture Set and Flexible Protector in people with Larynx Cancer, run by Atos Medical AB at 5 sites in 4 countries.
Trial summary
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Cancer
- What is being tested?
- Puncture Set and Flexible Protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Dec 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- primary puncture during total laryngectomy
- secondary puncture some time after total laryngectomy
Who cannot join
- anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture
- not eligible to use a voice prosthesis for other reasons
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Spain1 site
Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona
Barcelona, 08025
About this study
Official title: Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.
- Conditions
- Larynx Cancer
- Being tested
- Puncture Set and Flexible Protector
- Keywords
- voice prosthesis, larynx cancer, laryngectomy
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puncture Set and Flexible ProtectorDevice
The Provox Vega Puncture Set will be used to create the tracheoesophageal puncture and place the voice prosthesis. In secondary punctures the Provox Flexible Protector may be used for pharynx protection.
| Study group | Role | What they receive |
|---|---|---|
| Puncture Set and Flexible Protector | Experimental | Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy Receives: Device: Puncture Set and Flexible Protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Procedure
As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.
Measured: immediate observation during surgery
Secondary outcomes (3)
Satisfaction of Physician
Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.
Measured: 1 month
Cost Effectiveness Calculation
cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set.
Measurements are: time needed to perform procedure
Measured: 1 month
Postoperative Results
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Larynx CancerStudies 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
- Model description
- Provox Vega Puncture Set
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frans JM Hilgers, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045057
- Sponsor's protocol ID
- UD743_FRITZ_MULTI
- Status last verified
- Jun 2021
- First submitted
- 6 Jan 2010
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy
- ClinicalTrials.gov ID
- NCT01045057
- Acronym / sponsor ID
- UD743_FRITZ_MULTI
- Conditions
- Larynx Cancer
- Keywords
- voice prosthesis, larynx cancer, laryngectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Provox Vega Puncture Set
| Arm | Type | Receives |
|---|---|---|
| Puncture Set and Flexible Protector | Experimental | Device: Puncture Set and Flexible ProtectorProvox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during 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)
- primary puncture during total laryngectomy
- secondary puncture some time after total laryngectomy
Key exclusion criteria (2 listed)
- anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture
- not eligible to use a voice prosthesis for other reasons
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 |
|---|---|---|
| Puncture Set and Flexible ProtectorThe Provox Vega Puncture Set will be used to create the tracheoesophageal puncture and place the voice prosthesis. In secondary punctures the Provox Flexible Protector may be used for pharynx protection. | Device | Puncture Set and Flexible Protector |
Primary outcome
Success Rate of Procedure
Time frame: immediate observation during surgery
As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.
3 secondary outcomes
Satisfaction of Physician
Time frame: 1 month
Cost Effectiveness Calculation
Time frame: 1 month
Postoperative Results
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Frans JM Hilgers, MD, PhD principal investigator
The Netherlands Cancer Institute
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puncture Set and Flexible Protector in people with Larynx Cancer, run by Atos Medical AB at 5 sites in 4 countries.
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 2 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Belgium, Germany, Spain. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Success Rate of Procedure (time frame: immediate observation during surgery). 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 11 Jun 2021.