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

Lymphedema Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05628688
• Other study ID #: KCT 011 (VOLGA)
• Status: Recruiting
• Start date: August 8, 2023
• Est. completion date: August 28, 2024

Study information

• Verified date: February 2024
• Source: Koya Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 28, 2024
• Est. primary completion date: August 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Edema
• Lymphedema
• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

Diagnostic Test:
• Insight Pro Device for Diagnosis
Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders

Locations

Country	Name	City	State
United States	Koya Medical, Inc.	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Koya Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema Volume	Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.	Acute - At day 0
Primary	Fibrosis	Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement.	Acute - At day 0
Secondary	Safety/AEs	Safety during use (via adverse event reporting)	Acute - At day 0
Secondary	LymVAS	Correlation with quality-of-life objective parameters using a lymphedema visual analog scale	Acute - At day 0