Clinical trials: Breast Cancer Lymphedema
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.
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
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 Related Lymphedema
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.
- Trial name
- NCT04073823
- Testing
- Flexitouch Plus, Flexitouch Plus FT with software modification
- Where
- United States
- Volunteers
- 2 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
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
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.
Lymphedema, Lymphedema of Upper Arm
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
To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
- Conditions
- Lymphedema, Lymphedema of Upper Arm, Lymphedema, Breast Cancer
- Trial name
- NILE (NCT04908254)
- Testing
- Crossover Device (PCD or Dayspring - alternate to first group)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Koya Medical, Inc.
Breast Cancer Related Lymphedema, Lymphedema of Upper Arm
Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed.
- Conditions
- Breast Cancer Related Lymphedema, Lymphedema of Upper Arm, Lymphedema, Quality of Life
- Trial name
- DAYSPRING (NCT04659564)
- Testing
- User of Dayspring device
- Where
- 2 sites in United States
- Volunteers
- 40 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
Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT)
Based upon the current state of science, the investigators are proposing to conduct a randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up…
- Trial name
- NCT02167659
- Testing
- 23-32 mmHg compression sleeve with gauntlet
- Where
- 10 sites in United States, Australia
- Volunteers
- 1,201 people
- Sponsor
- ImpediMed Limited
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