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Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

Overview

About this study

This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patients for placement of the device into the mature Brooke ileostomy and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2 hours.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age range: 18 years and older.
  • Gender: Male and Female.
  • Target disease or condition: 20 patients with End Ileostomy, specifically Brooke ileostomy for at least 12 months.
  • Ability to comply with protocol.
  • Competent and able to provide written informed consent.

Exclusion Criteria:

  • Inability to provide consent.
  • Koch pouch.
  • Pregnancy.
  • Clinically significant medical conditions within the six months before participation with the device that would, in the opinion of the investigators, compromise the safety of the patient.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Faubion, M.D.

Open for enrollment

Contact information:

Jessica Friton

(507) 284-0495

Friton.Jessica@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20417928

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