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Clinical Research Studies

at 11 Health™

 

 

Our mission is to create more positive outcomes and promote a

better quality of life for patients suffering from chronic illnesses.

 

How we do that is by developing innovative wearable solutions

for individuals living with an ostomy.   

Clinical studies at 11 Health engage patient feedback in order to collect data and validate the effectiveness of our wearable products. Participants will be compensated in exchange for the completion of surveys and honest feedback about the products they are trialing.

Check out the detailed information below about our participation requirements, and eligibility.  

Participant Requirements

  • Optical images/videos of wafer and bag set-up 
  • Daily optical pictures/videos of stoma and surrounding skin 
  • Daily user feedback about wearability, collected by a dedicated research associate during the daily follow—up calls 
  • Questionnaires/Surveys about the product, filled out by the tester and recorded electronically 
  • Patient-reported times of drains 
  • Optical images as evidence of failure modes of any kind e.g. leaks 
  • Subjective description of stoma-related issues + Access to current medical information (including but not limited to; surgery data, postoperative complication history, current medications & treatments, etc.) 

Who is eligible for clinical trials

  • Have a stoma (ileostomy only) 
  • Above age 22
  • Fit Stoma profile (Regular or Outward) and (Protruding or Prolapsing) – For flat wafers.
  • Stoma diameter less than 32 mm 

Who is not eligible for clinical trials

  • Proven unable to use non-convex wafers (e.g. stoma protrusion of less than 0.5 cm/at skin level, or inward peristomal body contour) – For flat wafers 
  • Proven hypersensitivity reaction to any of the materials used in the device that come into direct contact with the skin 
  • Stoma diameter (measured from edge to edge of a stoma) in any distance > 32 mm (since the smart bag fits stoma size up to 32 mm)
  • Under 22 years of age 

Due to COVID-19, all of our clinical patient’s trials will be performed remotely 

Sign up to be contacted for our upcoming clinical research studies

If you have specific questions about our clinical patient studies please contact melanie.beltran@11health.com