Actively Recruiting
Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Restore Laryngeal Function
Led by University Hospital, Strasbourg, France · Updated on 2022-12-13
4
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Strasbourg, France
Lead Sponsor
E
Etablissement Français du Sang
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates a new approach to restore laryngeal function in patients who have undergone total laryngectomy due to laryngeal cancer. Total laryngectomy often leads to a permanent tracheostoma, severely affecting breathing, swallowing, and voice quality. Existing methods, including artificial larynx devices and laryngeal transplantation, have limitations, prompting researchers to explore a biological alternative using an aortic graft with a silicone stent to improve quality of life. The intervention involves a two-step surgical procedure. First, a total laryngectomy is performed, followed by placement of a stented aortic allograft made from human tissue and device components. The second surgery occurs between 24 and 36 weeks later, opening the proximal part of the graft endoscopically while maintaining the tracheotomy opening for safety. This approach aims to restore breathing, swallowing, and phonation functions. Participants will be monitored over time through visits assessing procedure success at six months post-second surgery and evaluating breathing difficulty, swallowing ability, and voice quality at multiple intervals up to twelve months. Researchers will also track adverse events for up to 28 months. Assessments include dyspnea scoring, swallowing evaluations, and the Voice Handicap Index 30 questionnaire to measure voice impact. This detailed follow-up aims to evaluate the overall safety and functional outcomes of the new laryngeal graft.
CONDITIONS
Brief Title
Aortic Laryngeal Rehabilitation Graft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with carcinomatous pathology of the upper airways requiring total laryngectomy
- Patient affiliated to a social health insurance scheme (beneficiary or beneficiary's successor)
- Patient speaks and reads French, understands the objectives and risks of the research and is able to provide dated and signed informed consent
- Patient having been informed of the results of the prior medical examination
- For women able to conceive: negative blood pregnancy test and effective contraception throughout the study
You will not qualify if you...
- Contraindication to general anaesthesia and/or iodinated contrast agents
- Breastfeeding woman
- WHO performance index greater than 2 at inclusion
- Subglottic or basi-lingual tumour extension greater than 1 cm
- Prior cervico-facial radiotherapy
- Severe coagulation disorders
- Allergy to DMSO, DHEA, clindamycin, gentamicin, or vancomycin
- Inability to provide informed consent
- Participation in another study exclusion period
- Under safeguard of justice, guardianship, curatorship, or family guardianship
- Any condition deemed non-eligible by the operating physician
- Decompensated psychiatric pathology or risk interfering with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of first surgical procedure
Participants undergo total laryngectomy and placement of the stented aortic allograft under tracheotomy cover.
1 visit (in-person)
Duration - Between 24 and 36 weeks after first surgery
Participants have a second surgery between 24 and 36 weeks after the first to open the proximal part of the graft endoscopically while maintaining the tracheotomy orifice for safety.
1 visit (in-person)
Duration - Up to 12 months after second surgery
Participants are monitored with assessments of breathing, swallowing, and voice at multiple follow-up visits to evaluate recovery and function.
Follow-up visits at 8 and 15 days, then at 1, 3, 6, 9, and 12 months after second surgery
Trial Site Locations
Total: 1 location
1
ENT department-Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
Actively Recruiting
Research Team
C
Christian DEBRY, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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