This is a feasibility study to assess this new device after 6 months use. There are 3 objectives that have to be fulfilled in order use this device in the future:1. Safety of the NewBreez® at 6 months: has there been further damage done to the…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety endpoints:
o Adverse events, including adverse device effects: dislocation, damage to the
larynx
o Implant tolerance
o Reversibility if/when removed
Secondary outcome
Performance and efficacy endpoints:
o Technical success of the implantation procedure
o Implant placement and integrity, as assessed by nasopharyngoscopy
o Eating (diet, oral intake and/or feeding tube dependency)
o Breathing (tracheotomy dependency)
o Aspiration, as assessed by direct visualization and videofluoroscopy at one
week and 6 months after placement
Patient satisfaction:
o Quality of Life, as assessed by the SWAL-QOL questionnaire
o Specific questions on tolerance and problems with the device
Background summary
Head and neck cancer (HNC) treatment may lead to early and late side effects
and complications which affect organ function. Since the larynx plays a central
role in the mechanism of swallowing, respiration and voice production,
swallowing/respiratory problems are not uncommon following HNC treatment, which
may eventually lead to the need for a feeding tube (to ensure proper intake)
and/or a tracheotomy (to ensure an open respiratory tract and prevent pulmonary
infections). Sometimes a total laryngectomy (TLE) is the only resolution for
controlling severely disabling and potentially life-threatening aspiration
problems in patients with a dysfunctional larynx1. In order to ensure safe oral
intake without the need of a feeding tube, tracheotomy and/or a TLE, several
removable intralaryngeal devices has been developed to prevent aspiration of
food into the airway, while ensuring normal respiratory function. The NewBreez®
intralaryngeal prosthesis is a silicon device with a valve mechanism designed
to enable passage of air through a dysfunctional larynx while preventing
aspiration through the valve. It is designed to restore normal oral feeding.
The aim of this study is to trial this prosthesis in HNC patients with severe
respiratory and swallowing disorders related to a dysfunctional larynx, and to
investigate whether this device can be placed safely without complications an
can obviate the need for total laryngectomy.
Study objective
This is a feasibility study to assess this new device after 6 months use.
There are 3 objectives that have to be fulfilled in order use this device in
the future:
1. Safety of the NewBreez® at 6 months: has there been further damage done to
the larynx?
2. Performance and efficacy of the NewBreez® at 6 months: is the device
functioning and preventing aspiration and not causing any airway complications.
Would decanulation of the trachea cannula and removal of the PRG tube be an
option?
3. Patient satisfaction: is the patient satisfied and does he/she have improved
quality of life?
Study design
Non-randomized, open-label, prospective clinical feasibility study
Intervention
Placement of the NewBreez® Intralaryngeal prosthesis.
Study burden and risks
The general benefits of using the NewBreez® Intralaryngeal device include the
possibility to restore natural breathing and to allow natural feeding. As there
is a risk of obstruction with mucous and crusts, we will only include patients
with a tracheostomy to prevent this complication. There is a risk that there is
still aspiration when the food does not pass quickly through the upper
esophageal sphincter or in case of a dysfunctioning valve. A serious side
effect is that the patient will probably become aphonic and has a whispery
voice.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients who have been treated successfully for HNC and are free of disease minimally one year after treatment; and
- Patients with difficulties in feeding and/or breathing due to a dysfunctional larynx, necessitating prolonged (> 6 months) use of a (nasogastric or percutaneous) feeding tube and a tracheotomy, which are unlikely to be removed; and
- Patients who are motivated to undergo the operation; and
- Patients are willing to provide written informed consent prior to participation.
Exclusion criteria
- Patients under the age of 18 years; or
- Patients with clotting disorders; or
- Patients with Chronic Obstructive Pulmonary Disease (COPD); or
- Patients with recurrent or residual HNC disease; or
- Patients with upper esophageal obstruction or stenosis on videofluoroscopy; or
- Patients who are unfit to undergo general anaesthesia, as judged by the anaesthetist.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51129.031.14 |