Clinical Trials and Studies

• Fibralign Announces Start of European Lymphedema Prevention Clinical Study

  Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema.

  The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and require axillary lymph node dissection (ALND), a common surgical intervention that involves removal of compromised lymph nodes to address the spread of cancer. Peer reviewed publications have estimated that 15-25% of patients who undergo ALND develop breast cancer-related lymphedema (BCRL) due to the surgery. ALND combined with radiation therapy increases the likelihood of BCRL further up to 40%.

  Led by Dr. Dimitris Dionysiou, Associate Professor in Plastic Surgery at the Aristotle University of Thessaloniki (Greece) and principal investigator, the trial aims to demonstrate the effectiveness of BioBridge as a prophylactic remedy for reducing patient risk in development of lymphedema. This off-the-shelf solution would provide a much-needed treatment that could be utilized as a simple adjunct procedure in support of current cancer interventions, significantly advancing the quality of care for patients.
  
  About BioBridge® Collagen Matrix

  BioBridge is a sterile, biocompatible and biodegradable surgical mesh that recently received CE mark for use in the surgical support of lymphatic tissue repair. The certification mark confirms that BioBridge meets the requirements of the European Medical Devices Directive, which now allows Fibralign to market the product across the European Union and other CE mark countries. BioBridge is also commercially available in the US and has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and repair soft tissue. Published preclinical studies and early clinical usage have shown that BioBridge supports the repair of damaged lymphatic vessels that causes lymphedema.

  About Fibralign Corporation

  Fibralign Corporation is a commercial stage healthcare company that develops and manufactures advanced therapeutic biomedical devices designed to address significant unmet medical needs by utilizing its patented Nanoweave® 3D scaffolding technology. http://www.fibralignbio.com

  Contacts

  In Europe: Albert Huttenga, ahuttenga@fibralignbio.com, +31 651 750 078
  Greg King, CEO/President Fibralign Corp. gking@fibralignbio.com, +1 415 902 4721

  For information about the US study, visit: LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) - Full Text View - ClinicalTrials.gov

  Learn More >
• The International Lymphatic Disease and Lymphedema Patient Registry & Biorepository

  We invite you to participate in this highly significant development for the patient community. An international patient registry paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic diseases. We encourage all patients to participate in this important initiative.

  Learn More >
• 
  BIDMC Acupuncture for Breast Cancer Related Lymphedema Study

  Researchers at Beth Israel Deaconess Medical Center in Boston, MA are conducting a study to demonstrate the feasibility and effectiveness of acupuncture for patients with breast cancer related lymphedema.
  
  You may be eligible for this study if you have a single arm affected by lymphedema following breast cancer treatment.
  
  Participants will be paid $50 for their time and will receive acupuncture treatments free of charge.
  

  The study length is 6 weeks.
   
  All prospective study subjects who are not current patients of the lymphedema treatment clinic at BIDMC must first be evaluated by Dr. Singhal to assess if they are appropriate candidates for the study (a comprehensive lymphedema evaluation) and then have clinical measurements taken by a certified lymphedema therapist. (These two appointments are outside of the study).
   
  There are a total of 12 acupuncture sessions which take place over a 6-week period. Acupuncture sessions generally begin 1-2 weeks after a patient has had their baseline evaluation (lab work and clinical measurements). Clinical measurements are repeated at week 3 (midpoint) of the study. At the end of the study (week 6), participants have clinical measurements and bloodwork taken.
   
  There are two study groups (all patients are offered 12 acupuncture sessions regardless of initial group assigned!)—one group receives 12 acupuncture sessions right away during this 6 week period (after baseline evaluation), and the other group is monitored clinically for 6-weeks, but then receives their 12 acupuncture treatments after that time period.
   
  All parking-related costs are reimbursed by the study.

  Please contact the study team to find out more or to see if you are eligible:
  
  Dhruv Singhal, MD
  Email address: lymphaticsurgery@bidmc.harvard.edu
  Phone Number: 617-632-7827

• Systemic Therapy to Treat Lymphatic Malformations

  Clinical Trial at Stanford School of Medicine:

  Dr. Joyce Teng, MD, PhD at Stanford University School of Medicine, CA is conducting a clinical trial on the use of Sildenafil treatment for patients ages 6 months - 10 years of age with Lymphatic Malformations (LM).

  Participation involves visits to Stanford, as well as at local sub-sites being conducted in Chicago, IL, and Denver, Colorado. Duration is 20 - 52 weeks. There is no compensation for this study, but all travel is covered by Stanford.  A separate study is also being conducted, which involves genetic testing of patients with lymphatic malformations.

  To find out more information or to see if your child qualifies, please contact Elidia Tafoya, MPH, study coordinator, at 650-724-1982 or by email at etafoya@stanford.edu.  To view clinical study flyer, click here.

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• University of Missouri-Columbia (MU) lymphedema study for breast cancer survivors
  A new study is available through the University of Missouri-Columbia (MU) for breast cancer survivors who have been diagnosed with lymphedema. It uses interactive theatre and printed information compared to printed information alone to test whether an interactive approach is more effective than printed information alone in helping women stick to their lymphedema self-management regimens.

  For more information and/or scheduling a study appointment, please contact Pamela Ostby, PhD(c), RN, OCN® at 314/255-6677 or you can email leresearch@missouri.edu.

   

  Learn More >
• CLINICAL TRIALS
  A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn More >
• AMERICA’S CLINICAL RESEARCH HOSPITAL
  The National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, is the nation’s largest hospital devoted entirely to clinical research. Learn More >
• RESEARCH MATCH
  Connecting people who are trying to find research studies and researchers who are looking for people to participate in their studies. A free and secure registry that has been developed by major academic institutions across the country who want to involve you in the mission of helping today’s studies make a real difference for everyone’s health in the future. Learn More >
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