Establishment of an Artificial Larynx After Total Laryngectomy (LA)
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ClinicalTrials.gov Identifier: NCT01474005 |
Recruitment Status
: Unknown
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
First Posted
: November 17, 2011
Last Update Posted
: July 2, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinomatous Disease | Device: PROTIP MEDICAL ( Artificial larynx prosthesis) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Establishment of an Artificial Larynx After Total Laryngectomy |
Study Start Date : | October 2011 |
Estimated Primary Completion Date : | October 2013 |
Estimated Study Completion Date : | October 2013 |
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Device: PROTIP MEDICAL ( Artificial larynx prosthesis)
- Evaluation of the restoration of respiratory functions [ Time Frame: one year ]
4 items will be used:
- 0: no dyspnea
- 1: moderate dyspnea
- 2: significant dyspnea
- 3: major dyspnea
- Evaluation of the restoration of the ability to swallow by nasofibroscopy [ Time Frame: one year ]
3 items will be used:
- 1: no aspiration
- 2: moderate aspiration
- 3: massive aspiration

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy
Exclusion Criteria:
- Less than 18 years
- Contraindications to general anesthesia
- Any situation considered by the physician operator as an exclusion
- Pregnant women
- Lactating women
- Subglottic or basi-lingual tumor extension more than 1 cm
- Prior radiotherapy
- Severe coagulation disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474005
Contact: Christian DEBRY, PU-PH | 03.88.12.76.45 ext 33 | christian.debry@chru-strasbourg.fr |
France | |
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière | Recruiting |
Strasbourg, France, 67091 Strasbourg Cedex | |
Principal Investigator: Christian DEBRY, PU-PH | |
Sub-Investigator: Patrick HEMAR, PH | |
Sub-Investigator: Philippe SCHULTZ, PU-PH |
Responsible Party: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT01474005 History of Changes |
Other Study ID Numbers: |
4493 |
First Posted: | November 17, 2011 Key Record Dates |
Last Update Posted: | July 2, 2012 |
Last Verified: | June 2012 |
Keywords provided by University Hospital, Strasbourg, France:
laryngectomy artificial larynx breathing swallowing upper airway |