Trials / Terminated
TerminatedNCT02661646
Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)
Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 249 (actual)
- Sponsor
- Tactile Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Assessment of quality of life and symptoms changes in primary or secondary, unilateral or bilateral lower extremity lymphedema patients using an advanced pneumatic compression system.
Detailed description
Post-market, on label, multi-center, single arm, observational clinical trial of a prospective cohort of 300 subjects with primary or secondary, unilateral or bilateral, lower extremity lymphedema in the United States. All subjects will receive pneumatic compression treatment for 52 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Advanced Pneumatic Compression Device | Advanced Pneumatic Compression Device |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2023-02-01
- Completion
- 2023-02-01
- First posted
- 2016-01-22
- Last updated
- 2023-04-03
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02661646. Inclusion in this directory is not an endorsement.