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New treatment option for Dysphagia Rehabilitation
Official title Personalized Rehabilitation With Organ-Preserving Robotic RESA in Head and Neck Cancer
ClinicalTrials.gov ID: NCT07546045
What this study is testing
- What it's testing
- This study aims to evaluate whether an intensive and personalized speech, swallowing, and voice rehabilitation (SSVR) program can help preserve swallowing function in patients with head and neck cancer undergoing minimally invasive robotic-assisted extended "Sistrunk" surgery (RESA). Participants will undergo the RESA surgery as part of their standard care.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients scheduled for a surgery with robotic-assisted extended "Sistrunk" approach - multiport (RESA) with the Da Vinci Xi or SP robotic system for...
- Indication for speech, swallowing and voice rehabilitation after surgery
- Informed consent signature
- 18 years old or older at the time of informed consent signature
You likely can't join if
- Inability to give informed consent
- Inability to follow study procedures (FEES, VFSS, questionnaires, "intensive" SSVR or else)
- Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion...
- Inability to memorize one analytic and one compensatory exercise at screening visit
- Participation in another study with an investigational drug or medical device within the 30 days preceding and during the present investigation,
- previous enrolment into the current study,
See the full eligibility criteria
- Patients scheduled for a surgery with robotic-assisted extended "Sistrunk" approach - multiport (RESA) with the Da Vinci Xi or SP robotic system for: a. a primary tumor resection of (cohort 1) i. oropharyngeal (base of...
- Indication for speech, swallowing and voice rehabilitation after surgery
- Informed consent signature
- 18 years old or older at the time of informed consent signature
- Inability to give informed consent
- Inability to follow study procedures (FEES, VFSS, questionnaires, "intensive" SSVR or else)
- Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule,
- Inability to memorize one analytic and one compensatory exercise at screening visit
- Participation in another study with an investigational drug or medical device within the 30 days preceding and during the present investigation,
- previous enrolment into the current study,
- contraindication to iodine contrast media (Accupaque) oral intake, i.e known anaphylaxis.
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.