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NCT04116099 · ClinicalTrials.gov registry record
CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema
A clinical trial, sponsored by Tactile Medical.
- Terminated
- Registry status
- 63
- Enrollment target
NCT04116099: Clinical Trial study, sponsored by Tactile Medical.
NCT04116099 is a clinical trial that was terminated before completion, run by Tactile Medical. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04116099 was terminated before completion, sponsored by Tactile Medical.
- TERMINATED
- Registry status
- 63 participants
- Enrollment target
Study Summary
Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.
Primary Outcome
To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related complications.
Interventions
- OTHER Conservative care
- DEVICE Flexitouch Plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2021-11-24 |
Why NCT04116099 stopped before completion
NCT04116099 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Conservative care is the first listed.
NCT04116099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04116099 about?
NCT04116099 is a clinical study titled "CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema". Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.
What is the current status of trial NCT04116099?
This trial is currently terminated. The enrollment target is 63 participants. The study started on 2019-10-10. Estimated completion is 2021-11-24.
What interventions are being tested in trial NCT04116099?
The interventions under investigation include: Conservative care (OTHER), Flexitouch Plus (DEVICE).
Who is sponsoring clinical trial NCT04116099?
This trial is sponsored by Tactile Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
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