Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
Not Applicable
Recruiting
- Conditions
- PhlebolymphedemaLymphedemaChronic Venous Insufficiency
- Interventions
- Device: Dayspring
- First Posted Date
- 2024-05-17
- Last Posted Date
- 2024-05-20
- Lead Sponsor
- Koya Medical, Inc.
- Target Recruit Count
- 50
- Registration Number
- NCT06418282
- Locations
- 🇺🇸
Glenn Jacobowitz, New York, New York, United States
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Recruiting
- Conditions
- LymphedemaEdemaChronic Venous InsufficiencyVenous Insufficiency of Leg
- Interventions
- Diagnostic Test: Insight Pro Device for Diagnosis
- First Posted Date
- 2022-11-29
- Last Posted Date
- 2024-02-16
- Lead Sponsor
- Koya Medical, Inc.
- Target Recruit Count
- 100
- Registration Number
- NCT05628688
- Locations
- 🇺🇸
Koya Medical, Inc., Oakland, California, United States
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
Not Applicable
Completed
- Conditions
- Lymphedema, Lower LimbChronic Venous InsufficiencyVenous InsufficiencyLymphedemaLymphedema of Leg
- Interventions
- Device: Cross over Device (PCD or Dayspring - alternate to first group)
- First Posted Date
- 2022-08-19
- Last Posted Date
- 2024-03-25
- Lead Sponsor
- Koya Medical, Inc.
- Target Recruit Count
- 121
- Registration Number
- NCT05507346
- Locations
- 🇺🇸
Stanley G Rockson, Oakland, California, United States
A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema
Not Applicable
- Conditions
- Lymphedema of Upper ArmLymphedemaLymphedema, Breast Cancer
- Interventions
- Device: Crossover Device (PCD or Dayspring - alternate to first group)
- First Posted Date
- 2021-06-01
- Last Posted Date
- 2021-06-01
- Lead Sponsor
- Koya Medical, Inc.
- Target Recruit Count
- 50
- Registration Number
- NCT04908254
- Locations
- 🇺🇸
Ginger-K Lymphedema & Cancer Center, Morgan Hill, California, United States
🇺🇸PT works, Los Altos, California, United States
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Not Applicable
Completed
- Conditions
- Secondary LymphedemaLymphedemaLymphedema Lower ExtremityChronic Venous Insufficiency
- Interventions
- Device: Dayspring Active Wearable Compression System
- First Posted Date
- 2021-05-21
- Last Posted Date
- 2022-12-01
- Lead Sponsor
- Koya Medical, Inc.
- Target Recruit Count
- 52
- Registration Number
- NCT04897035
- Locations
- 🇺🇸
PT works, Los Altos, California, United States
🇺🇸Ginger-K Lymphedema & Cancer Center, Morgan Hill, California, United States
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery
Not Applicable
- Conditions
- Lymphedema, Breast CancerLymphedemaLymphedema Arm
- Interventions
- Device: Dayspring Active Wearable Compression System
- First Posted Date
- 2021-05-17
- Last Posted Date
- 2021-05-20
- Lead Sponsor
- Koya Medical, Inc.
- Target Recruit Count
- 20
- Registration Number
- NCT04888975
- Locations
- 🇺🇸
Dung Nguyen, MD, PharmD, Palo Alto, California, United States
Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
Not Applicable
Completed
- Conditions
- Quality of LifeLymphedema of Upper ArmBreast Cancer Related LymphedemaLymphedema
- Interventions
- Device: User of Dayspring device
- First Posted Date
- 2020-12-09
- Last Posted Date
- 2021-06-01
- Lead Sponsor
- Koya Medical, Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT04659564
- Locations
- 🇺🇸
PT works, Los Altos, California, United States
🇺🇸Ginger-K Lymphedema & Cancer Center, Morgan Hill, California, United States
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