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Due to slow enrollment during COVID
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Pneumatic Compression Group | All study participants will receive treatment using an advanced pneumatic compression device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Pneumatic Compression Device | Device | Advanced Pneumatic Compression Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life changes: Questionnaires | Questionnaires to assess quality of life changes after 12 weeks of treatment | 12 weeks |
| Lymphedema symptom changes | Questionnaires [Lymphedema Quality of Life Tool (LYMQOL)] to assess lymphedema. symptom changes after 12 weeks of treatment. LYMQOL includes sub-scores for Function (range 8-32), Appearance (range 7-28), Symptoms (range 5-20), and Mood (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome. | 12 weeks |
| Number of lymphedema and venous related healthcare visits | Comparison of the number of lymphedema and venous related health care visits the year preceding treatment and the during the 52 weeks while receiving treatment (or until study exit) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Limb circumference changes after 12 weeks and 52 weeks of treatment | Comparison of changes in limb circumference after 12 weeks and 52 weeks of treatment | 12 weeks and 52 weeks |
| Fibrosis grading changes after 12 weeks and 52 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Primary or secondary, unilateral or bilateral, lower extremity lymphedema patients using the Flexitouch system during a 52 week study period.
*Note: Only Veteran's are eligible as this study is run through The Department of Veterans Affairs New York Harbor Healthcare System.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Maldonado, MD | NYU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Healthcare System | Baltimore | Maryland | 21201 | United States | ||
| VA New Jersey Health Care System (VANJHCS) |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 23, 2023 | |
| Reset | Feb 8, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2019 |
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Comparison of fibrosis grading (range Grade 0 to Grade 3, a lower grade represents a better outcome) after 12 weeks and 52 weeks of treatment
| 12 weeks and 52 weeks |
| Assessment of skin changes after 12 weeks and 52 weeks of treatment | Comparison of changes in the presence of skin conditions based on clinician observation after 12 weeks and 52 weeks of treatment | 12 weeks and 52 weeks |
| Lymphedema staging changes after 12 weeks and 52 weeks of treatment | Comparison of lymphedema staging (range Grade 0 to Grade 3, a lower grade represents a better outcome) after 12 weeks and 52 weeks of treatment | 12 weeks and 52 weeks |
| Quality of life changes: Questionnaires | Questionnaires to assess quality of life changes after 24 weeks of treatment | 24 weeks and 52 weeks |
| East Orange |
| New Jersey |
| 07018 |
| United States |
| VA NY Harbor Healthcare System - Brooklyn | Brooklyn | New York | 11209 | United States |
| VA Western New York Healthcare System | Buffalo | New York | 14215 | United States |
| VA NY Harbor Healthcare System - St. Albans | Jamaica | New York | 11425 | United States |
| VA NY Harbor Healthcare System - Manhattan | New York | New York | 10010 | United States |
| Mar 29, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2021 | Mar 29, 2023 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 23, 2023 | Feb 8, 2024 |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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