A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck L… (NCT03558672) | Clinical Trial Compass
TerminatedNot Applicable
A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema
Stopped: Low enrollment numbers
United States18 participantsStarted 2018-09-14
Plain-language summary
The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* A diagnosis of head and/or neck lymphedema
* Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation
* Head and chest measurements within the following:
* Crown of head circumference: ≤ 72 cm
* Chest circumference: ≤ 158 cm
* Prescribed the Flexitouch system or Flexitouch Plus
Exclusion Criteria:
* Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression)
* Carotid sinus hypersensitivity syndrome
* Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
* Symptomatic bradycardia in the absence of a pacemaker
* Internal jugular venous thrombosis (within 3 months)
* Increased intracranial pressure or other contraindications to internal or external jugular venous compression
* Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative
* Facial or head and neck dermal metastasis
* Acute facial infection (e.g., facial or parotid gland abscess)
* Any condition in which increased venous and lymphatic return is undesirable
* Heart failure (acute pulmonary edema, decompensated acute heart failure)
* Subject is pregnant or trying to become pregnant
* Acute venous disease (acute thrombophlebitis, acute deep venous …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptom/Problem Improvement From Baseline to 6 Months
Timeframe: Percent Changes between Baseline and 6 months will be assessed
2
Function (Range of Motion) Improvement From Baseline to 6 Months
Timeframe: Percent Changes between Baseline and 6 months will be assessed