Swallowing DisordersNCT01587664
NewBreez Safety and Efficacy Evaluation
A study testing NewBreez ILP in people with Swallowing Disorders, run by ProTiP Medical at 2 sites in 2 countries.
Trial summary
The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Disorders
- What is being tested?
- NewBreez ILP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to Dec 2014
- 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
- Age > 18 years old
- Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
- Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
- Must be able to understand and be willing to provide written informed consent
Who cannot join
- Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
- Major swallowing disorder
- Existing coagulation disorder
- Previous esophageal stenting
- Life-expectancy < 12 months
- Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis
The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.
- Conditions
- Swallowing Disorders
- Being tested
- NewBreez ILP
- Keywords
- Swallowing disorders, Aspiration
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NewBreez ILPDevice
NewBreez ILP implantation
| Study group | Role | What they receive |
|---|---|---|
| NewBreez ILP | Experimental | Implantation of a NewBreez ILP Receives: Device: NewBreez ILP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspiration score at 1 month
Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study
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 posted30 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2014
Why it stopped: Due to lack of recruitment and loss of the French principal investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisordersStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProTiP Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Remacle, Prof., Principal investigator, UCL Mont-Godinne (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587664
- Sponsor's protocol ID
- PIL-02-PEC-1-A
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2012
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis
- ClinicalTrials.gov ID
- NCT01587664
- Acronym / sponsor ID
- PIL-02-PEC-1-A
- Conditions
- Swallowing Disorders
- Keywords
- Swallowing disorders, Aspiration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of recruitment and loss of the French principal investigator.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ProTiP MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Apr 2012 (estimated)
- 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 objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NewBreez ILP | Experimental | Device: NewBreez ILPImplantation of a NewBreez ILP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
- Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
- Must be able to understand and be willing to provide written informed consent
Key exclusion criteria (6 listed)
- Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
- Major swallowing disorder
- Existing coagulation disorder
- Previous esophageal stenting
- Life-expectancy < 12 months
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 |
|---|---|---|
| NewBreez ILPNewBreez ILP implantation | Device | NewBreez ILP |
Primary outcome
Aspiration score at 1 month
Time frame: 1 month
Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study
Results and safety
The study was stopped early (reason given: Due to lack of recruitment and loss of the French principal investigator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- 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. This study is not recruiting at the moment.
Marc Remacle, Prof. principal investigator
UCL Mont-Godinne (Belgium)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NewBreez ILP in people with Swallowing Disorders, run by ProTiP Medical at 2 sites in 2 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. 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 was stopped early (reason given: Due to lack of recruitment and loss of the French principal investigator.). Results are not available in the source record.
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?
Aspiration score at 1 month (time frame: 1 month). 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 Apr 2017.