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NCT05628688 · ClinicalTrials.gov registry record
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
A clinical trial, sponsored by Koya Medical.
- Completed
- Registry status
- 67
- Enrollment target
NCT05628688: Completed study, sponsored by Koya Medical.
NCT05628688 is a clinical trial that has completed, run by Koya Medical. The registered enrollment target is 67 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05628688 has completed, sponsored by Koya Medical.
- COMPLETED
- Registry status
- 67 participants
- Enrollment target
Study Summary
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Primary Outcome
Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
Interventions
- DIAGNOSTIC_TEST Insight Pro Device for Diagnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2025-12-04 |
What the finished NCT05628688 record still lists
NCT05628688 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 67 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Insight Pro Device for Diagnosis is the first listed.
NCT05628688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05628688 about?
NCT05628688 is a clinical study titled "A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)". To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
What is the current status of trial NCT05628688?
This trial is currently completed. The enrollment target is 67 participants. The study started on 2023-08-08. Estimated completion is 2025-12-04.
What interventions are being tested in trial NCT05628688?
The interventions under investigation include: Insight Pro Device for Diagnosis (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05628688?
This trial is sponsored by Koya Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.
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