Breast Cancer Trial, Recruiting NCT04888975 Sponsor: Koya Medical, Inc. Condition: Breast Cancer
Back to Breast Cancer

Breast Cancer Trial, Recruiting

NCT04888975
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older (male or female)
  • You are willing and able to sign a consent form and follow the study's instructions
  • You have been diagnosed with swelling (edema) in your upper arm or hand, and you are having or planning to have lymphatic surgery with Dr. Nguyen
  • The difference in size/volume between your two arms is greater than 3%

Who may not be able to join:

  • You have a health condition affecting your whole body that could make compression therapy (gentle pressure treatment) unsafe for you
  • You are unwilling or unable to take part in all parts of the study, or cannot give your informed consent
  • Your physical exam results show something that would make the study device unsafe to use, such as a skin infection, open wounds, or healing wounds
  • You have been diagnosed with active or returning cancer, or it has been less than 3 months since you finished chemotherapy, radiation, or surgery to treat cancer
  • You have a diagnosed mental or physical condition that would make it hard to use the study device
  • You have been diagnosed with lipedema (a condition causing abnormal fat build-up, usually in the legs)
  • You currently have an active infection that has not been treated for at least 2 weeks
  • You have had an inflamed vein (thrombophlebitis) in the last 2 months
  • You have had a blood clot in the lung or in a deep vein within the last 6 months
  • You have been diagnosed with fluid in the lungs (pulmonary edema)
  • You have uncontrolled congestive heart failure (a condition where the heart does not pump well enough)
  • You have been diagnosed with chronic kidney disease
  • You have been diagnosed with epilepsy
  • You have poorly controlled asthma
  • You are pregnant, planning to become pregnant, or currently breastfeeding
  • You have taken part in another clinical trial in the past 30 days
  • You have swelling in both arms at the same time

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 4158510337

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Koya Medical, Inc.
Registry
ClinicalTrials.gov
Start date
1 June 2021
Est. completion
31 December 2021

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

ICG Fluorescence Lymphatic Imaging

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov