Clinical trials: Lymphedema
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 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
Assessment of Unilateral Lymphoedema of the Leg
To demonstrate that ImpediMed L-Dex U400 can be used to assess unilateral Lymphoedema of the leg using the same principles for arms.
- Trial name
- NCT00757406
- Where
- Australia
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- ImpediMed Limited
Open Surgery, Lymphedema
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery.
- Conditions
- Open Surgery, Lymphedema, Free Tissue Transfer, Microsurgery
- Trial name
- PRECISE (NCT06725030)
- Testing
- Symani Surgical System
- Where
- 6 sites in United States
- Volunteers
- 455 people
- Sponsor
- MMI (Medical Microinstruments, Inc.)
Lower Extremity Lymphoedema, Leg Lymphoedema
Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.
- Trial name
- NCT02031627
- Testing
- pneumatic compression - 1 hour per day, pneumatic compression - 2 hours per day, pneumatic compression - 4 hours per day
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- Tactile Medical
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
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
Head and Neck Neoplasms, Head and Neck Lymphedema
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema
Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.
- Conditions
- Head and Neck Neoplasms, Head and Neck Lymphedema, Head and Neck Cancer
- Trial name
- NCT02946021
- Testing
- Head and neck garments for pneumatic compression device, NIRFLI with ICG
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Tactile Medical
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, 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, Lymphedema, Breast Cancer
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
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
- Conditions
- Lymphedema, Lymphedema, Breast Cancer, Lymphedema Arm
- Trial name
- TIGRIS (NCT04888975)
- Testing
- Dayspring Active Wearable Compression System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Koya Medical, Inc.
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
Open Surgery, Lymphedema
A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis
The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery.
- Conditions
- Open Surgery, Lymphedema, Free Tissue Transfer, Microsurgery
- Trial name
- PRIME (NCT06628219)
- Testing
- Symani Surgical System
- Sponsor
- MMI (Medical Microinstruments, Inc.)
Primary Body Region (Arranged Most Common to Least), Lumbar/SI
ATI Evidence-based Guide Investigating Clinical Services
The goal of this study is to evaluate how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value in patients receiving…
- Conditions
- Primary Body Region (Arranged Most Common to Least), Lumbar/SI, Knee, Shoulder
- Trial name
- AEGIS (NCT02285868)
- Where
- United States
- Volunteers
- 4,000,000 people, healthy volunteers welcome
- Sponsor
- ATI Holdings, LLC
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
Lower Extremity Lymphedema
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
The goal of this pilot study is to learn if a revised method of compression improves lymphatic function compared to the current method of compression.
- Trial name
- NCT07613931
- Testing
- Advanced pneumatic compression device (APCD), Advanced pneumatic compression device (APCD) with revised compression programming, Indocyanine Green (IC-Green)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Tactile Medical
Secondary Lymphedema
A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema
Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer. Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema…
- Trial name
- NCT02994771
- Testing
- Lymfactin® [1 x 10E10 vp], Lymfactin® [1 x 10E11 vp]
- Where
- 3 sites in Finland
- Volunteers
- 15 people
- Sponsor
- Herantis Pharma Plc.
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 of Upper Arm, Breast Cancer
Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
This proof of concept study will evaluate the ability of a new, ultrasound based technology called Bullseye Constructive Shearwave Interference (CSI) (trade name, Bullseye Elasticity Quantification) to measure lymphedema of the…
- Trial name
- NCT05278871
- Testing
- Constructive Shearwave Interference (CSI)
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Microelastic Ultrasound Systems Inc
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