An interventional study of Larynx Allograft Transplantation in Larynx Stenosis, Larynx Disease and Laryngectomy, sponsored by Mayo Clinic. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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Among 72 studies in Laryngeal Diseases with a site in United States — 15 open to participants now, 17 under way, 3 of them phase 3. Laryngeal Diseases · United States.
Among the 72 studies in Laryngeal Diseases with a site in United States, this one is the 53rd largest by planned enrollment of the 61 interventional ones that give a count, is one of 2 that started in 2023, is one of 16 with no phase, and was the 44th registered.
147 studies on the registry are indexed under Laryngeal Diseases; 26 are open to participants now.
Browse Laryngeal Diseases studies →15 of the 72 studies in Laryngeal Diseases with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Bicara Therapeutics · Sites in United States
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Laryngeal Diseases studies recruiting now, 17 (81%) set no upper age limit and 1 (5%) stops at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 22 · Phase 3 11 · Phase 4 4
First in 1996; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 50 across 109 interventional studies indexed under Laryngeal Diseases.
Median enrollment 46 across the 61 interventional studies, 368 across the 10 observational. Of the 52 that completed or were terminated, 24 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 72 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,270 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 2 studies filed under Laryngeal Diseases — fewer than ten, so there is no comparison to draw.
3 of the studies in Laryngeal Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07434583University of California, San FranciscoForce Sensor Study | 2027-01-31 |
| NCT06915454Vanderbilt-Ingram Cancer CenterHigh-Resolution PET-CT Imaging for Surgical Margin Visualization | 2027-05 |
| NCT06634823Medical University of South CarolinaEfficacy of Intramuscular Steroid Injection for Chronic Cough. | 2027-06-30 |
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Among the 72 studies in Laryngeal Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.
Patients with severe laryngeal or laryngotracheal incompetence without other reconstructive options will be considered for cadaveric laryngotracheal transplantation. Data will be collected from 10 patients and will include length of hospital stay, short-term complications, long-term complications, hospital readmission, return trips to the operating room (OR), rejection episodes and severity, swallowing function, ability to have tracheotomy tube decannulated, voice parameters, pulmonary function, development of anti-donor antibodies, and quality of life scores.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Potential subjects for this study include patients with severe laryngeal dysfunction or a previous laryngectomy. For the purposes of this study, severe laryngeal dysfunction is defined as the loss of normal laryngeal function resulting in significant dysphonia, dysphagia, or dyspnea.
Inclusion Criteria:
One of the following:
Exclusion Criteria:
Poor surgical candidacy secondary to poor physical/mental health as determined by a pre-operative medical evaluation
General medical status
Any systemic disease which would alter
Psychosocial parameters
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cadaveric laryngotracheal transplantation
Procedure: Larynx Allograft Transplantation
This study is a prospective clinical trial designed to assess the efficacy and safety of laryngeal transplantation. A total of 10 patients will be enrolled over a five-year timeframe. Study length is 5 years.
Survival of the allograft at the one-year visit.
Survival of the allograft as indicated by histological rejection grading.
Time frame: 1 year
Swallowing without aspiration at the one-year visit.
Time frame: 1 year
Voice Evaluation
Standard voice evaluation will include voice recordings, acoustic and aerodynamic measurements as compared to baseline measurements.
Time frame: 1 year
Pulmonary function
Pulmonary function values within normal range.
Time frame: 1 year
Ability to have tracheotomy tube decannulated
Ability to have tracheotomy tube decannulated after successful capping trials.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for May 2028, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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