Clinical trials: Lymphatic Edema
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
Mastectomy; Lymphedema
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study
A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE DEVICE EFFICACY BETWEEN THE HELIXAR ELECTROSURGICAL GENERATOR (HEG) VS. CONVENTIONAL ELECTROSURGICAL COAGULATION (CEC) FOR CUTTING AND/OR COAGULATION OF TISSUE DURING…
- Trial name
- CHEST (NCT04165525)
- Testing
- Ablation
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- SurgiQuest, Inc.
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
Phlebolymphedema, Lymphedema
Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
- Conditions
- Phlebolymphedema, Lymphedema, Chronic Venous Insufficiency
- Trial name
- GRANDE (NCT06418282)
- Testing
- Dayspring
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Koya Medical, Inc.
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
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
Microsurgery, Lymphedema
CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System
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
- Microsurgery, Lymphedema, Free Tissue Transfer
- Trial name
- CONNECT (NCT06866197)
- Testing
- Symani Surgical System
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- MMI (Medical Microinstruments, Inc.)
Lymphedema, Lymphedema of Face
Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani
The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.
- Conditions
- Lymphedema, Lymphedema of Face, Internal Lymphedema, External Lymphedema
- Trial name
- CLEAR (NCT07311876)
- Testing
- Symani Surgical System
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- MMI (Medical Microinstruments, Inc.)
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
Breast Cancer Lymphedema
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the…
- Trial name
- NCT04432727
- Testing
- Flexitouch Plus with Cellular Connectivity (FT-CC)
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Tactile Medical
Secondary Lymphedema
Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)
This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo.
- Trial name
- AdeLE (NCT03658967)
- Testing
- Lymfactin® (1x10E11 vp)
- Where
- 5 sites in Finland, Sweden
- Volunteers
- 39 people
- Sponsor
- Herantis Pharma Plc.
Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or…
- Conditions
- Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Acquired Lymphedema, Congenital Lymphedema
- Trial name
- NCT01273909
- Testing
- Perforator Flap Breast Reconstruction, Vascularized Lymph Node Transfer
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- The National Institute of Lymphology
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 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
Head and Neck Neoplasms, Head and Neck Cancer
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.
- Conditions
- Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Lymphedema
- Trial name
- NCT03332160
- Testing
- Flexitouch head and neck lymphedema treatment system, Standard home lymphedema care
- Where
- 2 sites in United States
- Volunteers
- 49 people
- Sponsor
- Tactile Medical
Lipedema, Lipolymphedema
Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
Lipedema is a connective tissue disorder that affects up to 10% of women. It is characterized by painful, swollen subcutaneous tissue and disproportionate fat accumulation (primarily in the lower limbs, however it can spread to…
- Trial name
- NCT04213989
- Testing
- Flexitouch Plus and Conservative Care, Conservative Care
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Thomas Wright, MD
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
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, 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
The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device
The purpose of this project is to prove that the Imp™SFB7+ (L-Dex U400) is equivalent to the Imp™ XCA device in assessing Lymphoedema. The Imp™ XCA device is a simple device capable of assessing Lymphoedema of a single arm.
- Trial name
- NCT00766935
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ImpediMed Limited