Clinical trial NCT05628688: A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Official title: A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Chronic Venous Insufficiency
Edema
Venous Insufficiency of Leg
Lead sponsor: Koya Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (Test Group) - Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity.

(Control Group) Up to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema.

Brief summary: To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.

Detailed description: 6. Clinical Hypotheses

1. The Insight Pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
2. The Insight Pro device can detect a difference in skin hardness or fibrositis through a durometer measurement.
3. The Insight Pro device is safe for use as assessed by adverse events.

Eligibility criteria: 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
  * Diagnosis of congestive heart failure (uncontrolled)
  * Diagnosis of chronic kidney disease with acute renal failure
  * Women who are pregnant, planning a pregnancy or nursing at study entry
  * Participation in any clinical trial of an investigational substance or device during the past 30 days

Primary outcomes:
measure: Edema Volume
timeFrame: Acute - At day 0
measure: Fibrosis
timeFrame: Acute - At day 0
Secondary outcomes:
measure: Safety/AEs
timeFrame: Acute - At day 0
measure: LymVAS
timeFrame: Acute - At day 0
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Koya Medical, Inc.
state: California
Study officials:
References: