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NCT05628688 | RECRUITING | Lymphedema

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Sponsor:

Koya Medical, Inc.

Location

RECRUITING

United States, California

Koya Medical, Inc.

Oakland, California, United States, 94607

Brief Summary:

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

Condition or disease

Lymphedema

Chronic Venous Insufficiency

Edema

Venous Insufficiency of Leg

Intervention/treatment

Insight Pro Device for Diagnosis

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
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)
Actual Study Start Date : 2023-08-08
Estimated Primary Completion Date : 2024-08-28
Estimated Study Completion Date : 2024-08-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)

Location Details

NCT05628688

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