COMPLETED

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

Conditions

Lymphedema Chronic Venous Insufficiency Edema Venous Insufficiency of Leg

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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)

Quick Facts

Study Start:2023-08-08

Study Completion:2025-12-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05628688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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	* ● 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

Inclusion Criteria

Exclusion Criteria

* 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
* 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

* ● 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

Contacts and Locations

Study Locations (Sites)

Koya Medical, Inc.

Oakland, California, 94607

United States

Collaborators and Investigators

Sponsor: Koya Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08

Study Completion Date2025-12-04

Study Record Updates

Study Start Date2023-08-08

Study Completion Date2025-12-04

Terms related to this study

Additional Relevant MeSH Terms

Lymphedema
Chronic Venous Insufficiency
Edema
Venous Insufficiency of Leg