Recruiting

Testing a new graft to restore voice and breathing after larynx removal

Plain-English translation of NCT04650919 on ClinicalTrials.gov ↗ · Source last updated December 2022 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing a new approach to help patients who have had their voice box surgically removed due to cancer. Researchers are using a specially prepared tissue graft—made from donated human tissue treated with a preservation solution—to rebuild a functional larynx that might restore both normal breathing and voice. The goal is to help patients avoid wearing a permanent breathing tube in their neck and regain more normal quality of life.

When advanced laryngeal cancer requires complete removal of the voice box, patients currently lose their voice and must wear a permanent opening in their neck for breathing. Existing options either require lifelong anti-rejection medications (which aren't safe for cancer patients) or cause swallowing problems. This trial exists to test whether the new tissue graft approach can solve these problems and restore more natural function.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced throat cancer requiring complete removal of your larynx
you are able to understand and speak French, and can provide signed informed consent
you are enrolled in a French health insurance scheme
you are in reasonably good overall health (WHO performance status 0, 1, or 2)
you have not previously received radiation therapy to the head and neck area

You likely don't qualify if…

you cannot safely receive general anesthesia or contrast dye used in imaging
you have a history of severe bleeding or clotting disorders
you have a known allergy to any of the preservation chemicals used to treat the graft
you have untreated or unstable psychiatric conditions that would make it hard to follow the study plan
you are pregnant, breastfeeding, or unable to use effective contraception during the study

What participation looks like

If you qualify, you would undergo surgery to receive the specially prepared tissue graft to rebuild your larynx. This is a one-time surgical procedure performed at the University Hospital in Strasbourg, France, with follow-up visits to monitor how well the graft is working and whether your breathing and voice function improve. The trial is enrolling a small number of patients (up to 4) to carefully track safety and effectiveness over time.

AI-generated summary from trial data · Jun 4, 2026 · Not medical advice

Trial locations(1 site)

France

ENT department-Hôpitaux Universitaires de Strasbourg, Strasbourg

Key details

Sponsor

University Hospital, Strasbourg, France

Collaborators

Etablissement Français du Sang

Enrollment target

~4 participants

Started

March 2021

Primary completion

March 2025

This trial's estimated completion date has passed — the record may not be fully up to date.

Age range

18 Years and older

Last updated on clinicaltrials.gov in December 2022.

Contact the research team directly

Reach out to the team running this trial. Response times vary — some teams are faster than others.

Central contact

Christian DEBRY, MD PhD

Hôpitaux Universitaires de Strasbourg

Interested in joining?

Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.