A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Devic… (NCT05628688) | Clinical Trial Compass
CompletedNot Applicable
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
United States67 participantsStarted 2023-08-08
Plain-language summary
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
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:
Test group -
* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have primary or secondary unilateral or bilateral upper or lower extremity edema
* At the time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable
Control group -
* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must not have primary or secondary edema and self-describe general healthy
Exclusion Criteria:
* ● Inability or unwillingness to participate in all aspects of the study protocol and/or failure to provide informed consent
* Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
* Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy, or primary surgery for the cancer)
* Patients with cardiac arrhythmia with pacemakers or other implanted electronic equipment
* Patients must not have implanted metal hardware in the limbs
* Patients undergoing external defibrillation
* Diagnosis of Acute infection (in the last four weeks)
* Diagnosis of acute thrombophlebitis (in last 2 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 2 months
* Dia…
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.