An interventional study of Flexitouch Plus system in Head and Neck Cancer, sponsored by Endeavor Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Endeavor Health · Not applicable, Interventional, and Treatment
The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.
Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
Browse Head and Neck Neoplasms studies →Endeavor Health is the lead sponsor of 110 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
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Exclusion Criteria:
Device: Flexitouch Plus system
A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.
Internal lymphedema measurement
The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device).
Time frame: 2 hours
External lymphedema measurement
Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device).
Time frame: 2 hours
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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