Evaluating the Heylo™ device for people with stomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the long-term benefits of the Heylo™ device, a digital leakage notification system designed for individuals with intestinal stomas. The device includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter that alerts users to changes in their baseplate status. By potentially reducing leakage incidents, the study aims to improve the quality of life for stoma patients. Participants will be monitored over time to assess the effectiveness of the device in real-world settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Are you at least 18 years old? \[Yes/No\]
2. Do you have an ileostomy or a colostomy? \[Yes/No\]
3. Have you used Heylo™ for less than seven days? \[Yes/No\]

Exclusion Criteria:

1\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]

Where it's running

• Coloplast A/S
  Humlebæk, Denmark Recruiting

Study contacts

• Study coordinator: Thomas Krarup Simonsen
• Email: dktksi@coloplast.com
• Phone: +4549111873

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Midline Stoma Outcomes

  This study tests outcomes for temporary ileostomies or colostomies placed through the midline incision to see how patients fare after stoma reversal.

  Recruiting Assiut University · Asyut, Asyut Governorate · NCT07616830

• Drug absorption in people with an ostomy

  This study will test whether commonly used psychotropic medicines and newer oral blood thinners reach expected levels in adults who have an ileostomy or colostomy.

  Recruiting WiGeV Klinik Ottakring · Vienna, State of Vienna · NCT07138326

• Efferent loop stimulation before ileostomy closure

  This study is testing if stimulating a part of the intestine with a special solution before closing an ileostomy can help patients recover better and have fewer complications after surgery.

  Recruiting Hospital Universitario La Paz · Madrid · NCT06974500

• Intensified omeprazole treatment to reduce high-output stoma in ileostomy patients

  This study tests if a stronger dose of omeprazole can help adults with ileostomy surgery have less stoma output and stay out of the hospital longer.

  Recruiting at 2 sites Medical University of Gdansk · Gdansk, Pomeranian Voivodeship and 1 other locations · NCT06917963

• Protective ileostomy vs protective colostomy after anterior rectal resection

  This study tests whether a loop ileostomy or a loop colostomy works better as a protective stoma after anterior rectal resection in adults.

  Recruiting at 3 sites Helsinki University Central Hospital · Helsinki and 2 other locations · NCT06650085

• Preoperative intestinal training with antegrade ileostomy infusion

  This trial will try infusing material from your ostomy bag back into your unused intestine before reversal surgery to see if it helps the bowel recover faster for people with a diverting loop ileostomy.

  Recruiting Phase 1/2 University of California, San Diego · La Jolla, California · NCT06461559

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.