Vocal Cord ParalysisPhase 2NCT00213863
Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
A Phase 2 study testing Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting in people with Vocal Cord Paralysis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Cord Paralysis
- What is being tested?
- Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Nov 2016
- Phase
- Phase 2
- 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
- Males or females greater than 18 years old
Who cannot join
- Age less than 18 years
- Pregnant women
- Local carcinoma excluding radiotherapeutic or surgical control
- Bad general condition
- Contraindication to general anesthesia
- Non-controlled diabetes
Trial locations and contacts
1 site in 1 country.
Christian Debry, MD contact
France1 site, 1 recruiting
- Recruiting
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Strasbourg
Christian Debry, MD, 33.3.88.12.76.45, christian.debry@chru-strasbourg.fr
Christian DEBRY, MD
About this study
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.
- Conditions
- Vocal Cord Paralysis
- Being tested
- Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
- Keywords
- porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick settingDevice
The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasofibroscopy
Measured: 8 days and 3 months after surgery
Voice control and recording
Measured: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
All types of complication
Measured: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2010
- Primary completionMay 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord ParalysisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Debry, MD, Principal investigator, Hopitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213863
- Sponsor's protocol ID
- 3097
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- 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
- Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
- ClinicalTrials.gov ID
- NCT00213863
- Acronym / sponsor ID
- 3097
- Conditions
- Vocal Cord Paralysis
- Keywords
- porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 21 Sep 2005 (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.
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.
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 (1 listed)
- Males or females greater than 18 years old
Key exclusion criteria (6 listed)
- Age less than 18 years
- Pregnant women
- Local carcinoma excluding radiotherapeutic or surgical control
- Bad general condition
- Contraindication to general anesthesia
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 |
|---|---|---|
| Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick settingThe porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting. | Device | – |
Primary outcome
Nasofibroscopy
Time frame: 8 days and 3 months after surgery
Voice control and recording
Time frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
All types of complication
Time frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
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 contact
Christian Debry, MD principal investigator
Hopitaux 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 2 study testing Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting in people with Vocal Cord Paralysis, 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 1 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: 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (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?
Nasofibroscopy (time frame: 8 days and 3 months after surgery). The study lists 3 primary outcomes in all. 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.