Pharyngeal NeoplasmsPhase 1NCT00396617
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
A Phase 1 study testing prothesis voice and total laryngectomy in people with Pharyngeal Neoplasms and Laryngeal Neoplasms, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma
- What is being tested?
- prothesis voice and total laryngectomy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Mar 2014
- Phase
- Phase 1
- 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 more than 18
- total laryngectomy or pharyngo-larynctomy
Who cannot join
- pregnant women-age less than 18
- major pulmonary bronchitis
- major neurological disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67082
Christian DEBRY, MD, 33.3.88.12.76.44, christian.debry@chru-strasbourg.fr
Patrick HEMAR, MD
About this study
The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions
- Conditions
- Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma
- Being tested
- prothesis voice, total laryngectomy
- Keywords
- Laryngeal or pharyngo-laryngeal's carcinoma,, voice prosthesis tracheooesophageal shunt,, titanium beads,, cellular colonization, Laryngeal or pharyngo-laryngeal's carcinoma
- Medical subject headings
- Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prothesis voiceDevice
The device may be used for patient using another type of voice prosthesis, of for patient undergoing total laryngectomy. This device is definitively placed in two parts:The first one is introduced in the puncture (TEP) through the esophagus (retrograde way). The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
total laryngectomyProcedure or surgery
The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical measures concerning peri and intra prosthetic leakage
Measured: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36
Secondary outcomes (1)
Phonology's measures
Measured: months 1, 3,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startDec 2007
- Primary completionSep 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- OseoAnvar, Réseau National des Technologies de Santé
- Responsible party
- Sponsor
- Investigators
- Christian DEBRY, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396617
- Sponsor's protocol ID
- 3736
- Status last verified
- Jun 2012
- First submitted
- 6 Nov 2006
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
- ClinicalTrials.gov ID
- NCT00396617
- Acronym / sponsor ID
- 3736
- Conditions
- Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma
- Keywords
- Laryngeal or pharyngo-laryngeal's carcinoma,, voice prosthesis tracheooesophageal shunt,, titanium beads,, cellular colonization, Laryngeal or pharyngo-laryngeal's carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- OseoAnvar, Réseau National des Technologies de Santé
- Study start
- Dec 2007
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 7 Nov 2006 (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 benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age more than 18
- total laryngectomy or pharyngo-larynctomy
Key exclusion criteria (3 listed)
- pregnant women-age less than 18
- major pulmonary bronchitis
- major neurological disorders
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 |
|---|---|---|
| prothesis voiceThe device may be used for patient using another type of voice prosthesis, of for patient undergoing total laryngectomy. This device is definitively placed in two parts:The first one is introduced in the puncture (TEP) through the esophagus (retrograde way). The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary. | Device | – |
| total laryngectomyThe second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary. | Procedure or surgery | – |
Primary outcome
Clinical measures concerning peri and intra prosthetic leakage
Time frame: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36
1 secondary outcome
Phonology's measures
Time frame: months 1, 3,12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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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.
Christian DEBRY, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing prothesis voice and total laryngectomy in people with Pharyngeal Neoplasms and Laryngeal Neoplasms, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Jul 2012. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian DEBRY, MD (33.3.88.12.76.44, christian.debry@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical measures concerning peri and intra prosthetic leakage (time frame: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36). 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 2 Jul 2012.