Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

Overview

About this study

The purpose of this research is to study the performance of a device called PrevisEA, an investigational device not approved by the Food and Drug Administration (FDA). This research is sponsored by the maker of the PrevisEA device, Entac Medical Inc. This device listens to and records abdominal sounds which provides data that can help predict gastrointestinal impairment (GII). GII is a condition that is defined as the failure of oral re-feeding after abdominal surgery.

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:

  • ≥ 18 and ≤ 90 years of age.
  • Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
    • Segmental ileocolic resection with or without diversion;
    • Segmental colon resection with or without diversion;
    • Segmental coloproctectomy with or without diversion;
    • Low anterior resection with or without diversion;
    • Abdominoperineal resection;
    • Total abdominal colectomy with or without diversion;
    • Proctocolectomy with or without end ileostomy or diversion;
    • Closure of end colostomy (Hartmann’s reversal).

Exclusion Criteria:

  • Allergies to any of the device components (i.e., adhesive).
  • Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations (e.g., fistulas, stomas, drains, etc.).
  • Patients undergoing:
    • Small bowel resection without colonic resection;
    • Transanal proctectomy without transabdominal approach;
    • Perineal proctosigmoidectomy;
    • Closure of loop colostomy or ileostomy.
  • Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection.

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

Kellie Mathis, M.D.

Open for enrollment

Contact information:

Yulia Potter Nichols

(507) 422-9029

PotterNichols.Yulia@mayo.edu

More information

Publications

Publications are currently not available