Clinical trials: Lymphedema of Limb
Lymphedema, Lymphedema of Leg
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
To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
- Conditions
- Lymphedema, Lymphedema of Leg, Chronic Venous Insufficiency, Venous Insufficiency
- Trial name
- TEAYS (NCT05507346)
- Testing
- Cross over Device (PCD or Dayspring - alternate to first group)
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Koya Medical, Inc.
Lymphedema of Leg, Lymphedema
A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
This study will aim to undertake a preference evaluation comparing the Aria Health Aria Free™ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another.
- Conditions
- Lymphedema of Leg, Lymphedema, Lymphedema, Secondary, Lymphedema Primary
- Trial name
- NCT05485454
- Testing
- Aria Health Aria Free, A Traditional PCD
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
Lymphedema
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.
- Trial name
- NCT04116099
- Testing
- Conservative care, Flexitouch Plus
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Tactile Medical
Lymphedema
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.
- Trial name
- MARILYN (NCT02253186)
- Testing
- Auto-Adjustable MOBIDERM Armsleeve
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Thuasne
Lymphedema of Leg, Lymphedema Congenital
Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
MOBIDERM® demonstrated his interest through clinical studies on the treatment of lower or upper limb lymphedema (Mestre et al 2017; Quéré et al. 2014).
- Conditions
- Lymphedema of Leg, Lymphedema Congenital, Lymphedema Primary, Lymphedema, Secondary
- Trial name
- ACTIODERM (NCT04252690)
- Testing
- MOBIDERM® autofit : auto-adjustable compression stocking
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Thuasne
Primary Lower Limb Lymphedema, Secondary Lower Limb Lymphedema
Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).
- Trial name
- NCT02234674
- Testing
- Current intensive CDP, intensive CDP where Stendo pulsating suit replaces pressotherapy
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Stendo
Lymphedema
Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)
This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with…
- Trial name
- NCT02700529
- Testing
- ubenimex
- Where
- 4 sites in United States, Australia
- Volunteers
- 54 people
- Sponsor
- Eiger BioPharmaceuticals
Lymphedema, Lymphedema Lower Extremity
Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
- Conditions
- Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency, Secondary Lymphedema
- Trial name
- TIBER (NCT04897035)
- Testing
- Dayspring Active Wearable Compression System
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Koya Medical, Inc.
Lymphedema, Edema
LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the…
- Trial name
- NCT04606030
- Testing
- BioBridge® Collagen Matrix, Vascularized Lymph Node Transfer (VLNT)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Fibralign Corporation
Lymphedema of Upper Limb
Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related…
- Trial name
- LyberT (NCT06264817)
- Testing
- MOBIDERM Autofit Armsleeve, Compressive bandaging
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Thuasne
Lymphedema of Upper Arm
Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema
One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and…
- Trial name
- NCT03492476
- Testing
- Circaid, Short-stretching Bandage (Reference treatment)
- Where
- 4 sites in France
- Volunteers
- 142 people
- Sponsor
- CEN Biotech
Lymphedema of Upper Arm
Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer.
- Trial name
- LYMphoNIGHT (NCT04203069)
- Testing
- Control group : Day-time compression sleeve, Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit
- Where
- 8 sites in France, Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Thuasne
Lymphedema of Limb
Compact Pneumatic Compression Device for Patients With Lymphedema
This is a pilot study for usability and efficacy, and as such it is designed for 15 participants. The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting.
- Trial name
- NCT04226287
- Testing
- Monterey Pneumatic Compression Device
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- ResMed
Lymphedema, Edema
Surgical Evaluation for Upper Extremity Lymphedema (BioBridge)
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the…
- Trial name
- NCT05695924
- Testing
- BioBridge® Collagen Matrix, Vascularized Lymph Node Transfer (VLNT)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Fibralign Corporation
Lymphedema
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of…
- Trial name
- ACE (NCT01239160)
- Testing
- Flexitouch System, Hydroven FPR
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 238 people
- Sponsor
- Tactile Medical
Lymphedema, Secondary, Lymphedema of Upper Limb
LymphoPilot Test for Limb Lymphedema
The present study is a first-in-man, single arm, open-label, single center study to assess feasibility and safety of a novel implantable device, LymphoPilot, in patients suffering from secondary upper limb or lower lymphedema.
- Conditions
- Lymphedema, Secondary, Lymphedema of Upper Limb, Lymphedema Arm, Lymphedema of Leg
- Trial name
- NCT04858230
- Testing
- LymphoPilot
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Lymphatica Medtech SA
Breast Cancer Related Lymphoedema, Lymphoedema
LYT-100 in Patients With BCRL
This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema
- Trial name
- NCT04243837
- Testing
- LYT-100 BCRL
- Where
- 8 sites in United States, Australia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- PureTech
Lymphedema
Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)
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.
- Trial name
- NCT02661646
- Testing
- Advanced Pneumatic Compression Device
- Where
- 6 sites in United States
- Volunteers
- 249 people
- Sponsor
- Tactile Medical
Limb Lymphoedema
Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.
The aim of this cross-over, randomized study is to assess the efficacy and pressure maintenance of MOBIDERM Autofit versus bandages in the management of Breast Cancer Related Lymphedema (BCRL) in night-time maintenance phase.
- Trial name
- MOBISCAN (NCT07355959)
- Testing
- MOBIDERM Autofit Armsleeve, Self-bandages
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- Thuasne