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 range18 Years
SexALL
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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:
* â—Ź 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…