Clinical Trials and Studies
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The World’s First Implantable Device for Lymphedema Treatment
The study consists in a first-in-man clinical investigation for LymphoPilot, an investigational implantable medical device. LymphoPilot is composed of an implanted part and an external wearable device. The implanted part (pump, drainage catheter and output catheter), is implanted in the subcutaneous tissue of the arm and drains excess fluids to the supraclavicular subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The external part consists in a wearable controller used to activate the implanted pump.
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Lymphedema Patient Survey
Do you have lymphedema? Please respond to this anonymous on-line survey: Lymphedema Patient Survey
It will take only 3 minutes, but your participation is extremely important! The data that we collect will help us to inform doctors, hospitals, third party payers and the government about the lymphedema patient experience.
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Lymphatic Anatomy and Function Study - Breast Cancer Survivors
Researchers from the Boston Lymphatic Center at Beth Israel Deaconess Medical Center are conducting a study to identify normal variation in lymphatic anatomy in the upper extremities of female breast cancer survivors. For more information, download the flyer below.
Flyer_Breast_Cancer_Survivors.pdf
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Lymphatic Anatomy and Function Study - Healthy Volunteers
Researchers from the Boston Lymphatic Center at Beth Israel Deaconess Medical Center are conducting a study to identify normal variation in lymphatic anatomy in the upper extremities of healthy volunteers. For more information, download the flyer below.
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PureTech Health Study of Investigational Treatment for Lymphedema
PureTech Health is conducting a study to evaluate its investigational product candidate, LYT-100 (deupirfenidone), for the potential treatment of breast cancer related lymphedema. PureTech is committed to developing medicines for devastating diseases, and the company believes that LYT-100 has the potential to treat lymphedema.
Men and women between the ages of 18 and 80 with documented breast cancer-related lymphedema may be eligible to participate in this study.
Key Inclusion criteria:
1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
2. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy [FNA]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study.
3. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening.
4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study.
5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline.
6. Documented evidence of Stage 1 or 2 single arm lymphedema.Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022Contacts:
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Christopher Korth: +1 617-226-4813 ckorth@puretechhealth.com
Michael Chen: +1 617-226-4813 mc@puretechhealth.com -
Analysis of Role Changes for Women with Breast Cancer Related Lymphedema to Return to Work
IS THIS STUDY RIGHT FOR YOU?
❖ Have you been diagnosed with breast cancer related lymphedema?
❖ Do you experience difficulty with everyday tasks due to symptoms associated with breast cancer related lymphedema (BCRL)?
❖ Are you limited with your ability to perform successfully at work due to symptoms?
❖ Do you currently receive rehabilitation services for lymphedema management secondary to breast cancer?
❖ Inclusion criteria: female between the ages of 18-65, diagnosed with breast cancer or breast cancer related lymphedema.
❖ Exclusion criteria: outside of the age parameters listed in the inclusion, not a female, does not have a diagnosis of breast cancer or breast cancer related lymphedema.WHAT WOULD YOU HAVE TO DO?
● Participate in a short 15 question internet survey, answering the questions to the best of your ability.
● The survey will be anonymized, and no collection of any identifiable information will occur to avoid any violation of protection to the participants.
● Private message the study investigator on the Facebook support group to participate in the study.
This study is voluntary and you may withdraw at any time. Your information will be kept confidential and no information that could potentially identify you will be published.If you would like to receive more information regarding the study, please contact the investigator for this study:
Soraya Martinez, Occupational Therapy Doctorate Student at the University of St. Augustine for Health Sciences, Email: s.martinez@usa.edu; Phone number: 407-535-7749
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An update on the priorities for women living with breast cancer related lymphoedema
An update on the priorities for women living with breast cancer related lymphoedema and the relationship with severity
The University of Sydney is conducting an online survey looking at the needs of women living with breast cancer-related lymphoedema. Participation in this research study is voluntary. The survey will take approximately 20 minutes to complete.Women who have been diagnosed with breast cancer and as a result of treatment and have experienced upper limb swelling (lymphoedema). Women should have completed treatment for their breast cancer (except for hormone treatment) at least 6 months ago and have experienced upper limb lymphoedema for more than 12 months
A survey will be completed online which will investigate your needs arising from living with upper limb lymphoedema including:
· The severity of your lymphoedema.
· How lymphoedema has impacted your daily and working life.If you have breast cancer related lymphoedema with access to the internet using a computer, laptop, Ipad or smart phone we would love to hear from you!
To participate in the survey, click here.
If you have questions or would like more information about participating, please contact us at jfre8103@uni.sydney.edu.au.
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International research study looking at psychological well-being in lipoedema
The purpose of this project is to understand the experiences of women with lipoedema and its impact on their well-being. This project is being undertaken by Chantelle Clarke in fulfilment of the Doctor of Philosophy program within the School of Health, Medical and Applied Sciences at CQUniversity Australia under the supervision of Associate Professor Talitha Best (CQUniversity) and Dr. James Kirby (University of Queensland).
Women over 18 years of age with lipoedema (suspected or diagnosed) are eligible to participate in this study. Participation in this project involves the completion of an online survey which will take approximately 30-45 minutes to complete.
To contact the researchers for further information about this project, email the principle investigator Chantelle Clarke at c.clarke2@cqu.edu.au
For more information and the survey link, click here.
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LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)
The University of Chicago Medicine has announced that it is now enrolling patients in LymphBridge™, a randomized clinical study to evaluate a novel surgical treatment for addressing breast cancer-related lymphedema (NCT04606030). This study is sponsored by Fibralign Corporation with funding provided by the National Cancer Institute (NCI) and being led by world-renowned microsurgeon Dr. David W. Chang, Professor of Surgery and Chief of the Section of Plastic and Reconstructive Surgery at UChicago Medicine.
LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema is an FDA-reviewed clinical study that will assess Fibralign’s BioBridge® Collagen Matrix for use in improving outcomes of surgical treatment of lymphedema. BioBridge is a sterile, biocompatible and biodegradable device made of medical-grade collagen that has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and support soft tissue repair. In this study BioBridge will be implanted as part of the lymph node transplant surgery to support repair of damaged lymphatic tissue.
Estimated Primary Completion Date: September 30, 2022
Estimated Study Completion Date: December 15, 2022Contact: Janine Grohar 773-702-0316 jgrohar@bsd.uchicago.edu
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Exploring the Quality of life of children and young people with Lymphoedema
This study aims to explore the Quality of life of children and young people with Lymphoedema and to validate a Lymphoedema specific quality of life tool (LYMPHOQOL) for use with children and young people with Lymphoedema.
What is the purpose of the study?
This study aims to explore the Quality of life of children and young people with Lymphoedema and to validate a Lymphoedema specific quality of life tool (LYMPHOQOL) for use with children and young people with Lymphoedema.Why have I been invited?
You are being invited to take part because you or your child are living with Lymphoedema.What will happen to me if I take part?
You will be asked to complete 2 online questionnaires (LYMPHOQOL and KIDSCREEN) that are written in your own language and according to your age. These questionnaires aim to measure your quality of life and understand any worries you may be experiencing. You will also be asked to tell us what you think about the new LYMPHOQOL questionnaire and how long it took you to complete the online survey.Further information and contact details
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Professor Christine Moffatt, CBE,
Emeritus Professor University of Nottingham,
Clinical Professor of Skin Integrity,
Nottingham University Hospitals NHS Trust,
Nottingham City Hospital,
Hucknall Road,
Nottingham,
NG5 1RB
Email address: christine.moffatt@cricp.org.uk - 123