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NCT04335981 · ClinicalTrials.gov registry record · NA
Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression
A NA study, sponsored by Tactile Medical.
- Terminated
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT04335981: Clinical Trial NA study, sponsored by Tactile Medical.
NCT04335981 is a NA study that was terminated before completion, run by Tactile Medical. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04335981, a NA study, was terminated before completion, sponsored by Tactile Medical.
- TERMINATED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
The objective of the study is to assess the effect early pneumatic compression (prior to confirming cancer-free status via PET or CT imaging) has on swallow outcomes, positron emission tomography (PET) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyngeal cancer.
Primary Outcome
PAS is an eight-point ordinal severity scale scoring the depth of airway invasion by the bolus, whether it is expelled from the airway as well as any patient reaction. It ranges from one (material does not enter the airway) to eight (material enters the airway, passes below the vocal folds, and no effort is made to eject). Min value = 1, Max value = 8, the lower the score the better.
Interventions
- DEVICE FT-CC and Swallow Exercises
- OTHER Swallow Exercises
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2022-10-01 |
| Phase | NA |
Why NCT04335981 stopped before completion
NCT04335981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which FT-CC and Swallow Exercises is the first listed.
NCT04335981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04335981 about?
NCT04335981 is a clinical study titled "Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression". The objective of the study is to assess the effect early pneumatic compression (prior to confirming cancer-free status via PET or CT imaging) has on swallow outcomes, positron emission tomography (PET) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyng...
What is the current status of trial NCT04335981?
This trial is currently terminated. It is a NA study. The enrollment target is 22 participants. The study started on 2020-09-24. Estimated completion is 2022-10-01.
What interventions are being tested in trial NCT04335981?
The interventions under investigation include: FT-CC and Swallow Exercises (DEVICE), Swallow Exercises (OTHER).
Who is sponsoring clinical trial NCT04335981?
This trial is sponsored by Tactile Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04335981's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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