LymphedemaVOLGANCT05628688
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
An observational study of Lymphedema and Chronic Venous Insufficiency, run by Koya Medical, Inc. at 1 site in United States.
Trial summary
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Chronic Venous Insufficiency, Edema
- What is being tested?
- Insight Pro Device for Diagnosis
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 4 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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 -
Show all 9Show fewer
- 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
Who cannot join
- ● 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Read the detailed description
- Clinical Hypotheses
- The Insight Pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
- The Insight Pro device can detect a difference in skin hardness or fibrositis through a durometer measurement.
- The Insight Pro device is safe for use as assessed by adverse events.
- Being tested
- Insight Pro Device for Diagnosis
- Medical subject headings
- Lymphedema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insight Pro Device for DiagnosisDiagnostic test
Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders
| Study group | Role | What they receive |
|---|---|---|
| Test group | Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity. Receives: Diagnostic Test: Insight Pro Device for Diagnosis | |
| Control group | Up to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema. Receives: Diagnostic Test: Insight Pro Device for Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema Volume
Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
Measured: Acute - At day 0
Fibrosis
Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement.
Measured: Acute - At day 0
Secondary outcomes (2)
Safety/AEs
Safety during use (via adverse event reporting)
Measured: Acute - At day 0
LymVAS
Correlation with quality-of-life objective parameters using a lymphedema visual analog scale
Measured: Acute - At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start8 Aug 2023
- Primary completion28 Aug 2024
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koya Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628688
- Sponsor's protocol ID
- KCT 011 (VOLGA)
- Acronym
- VOLGA
- Status last verified
- Dec 2025
- First submitted
- 9 Nov 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05628688
- Acronym / sponsor ID
- VOLGA / KCT 011 (VOLGA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Koya Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Detailed description
- Clinical Hypotheses
- The Insight Pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
- The Insight Pro device can detect a difference in skin hardness or fibrositis through a durometer measurement.
- The Insight Pro device is safe for use as assessed by adverse events.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Diagnostic Test: Insight Pro Device for DiagnosisUp to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity. |
| Control group | – | Diagnostic Test: Insight Pro Device for DiagnosisUp to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- ● Inability or unwillingness to participate in all aspects of the study protocol and/or failure to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insight Pro Device for DiagnosisInsight Pro Device for Diagnosis of Lymphatic and Venous Disorders | Diagnostic test | Control group, Test group |
Primary outcome
Edema Volume
Time frame: Acute - At day 0
Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
Fibrosis
Time frame: Acute - At day 0
Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement.
2 secondary outcomes
Safety/AEs
Time frame: Acute - At day 0
LymVAS
Time frame: Acute - At day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphedema
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
RecruitingObservational study
Use of Reconstructive Microsurgery for the Treatment of Lymphedema
Lymphedema
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
Recruiting
Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
Breast Cancer
Active, not recruitingPhase 3
Hypofractionated LocoRegional Radiotherapy in Breast Cancer
Breast Neoplasms, Radiotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema and Chronic Venous Insufficiency, run by Koya Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema Volume (time frame: Acute - At day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.