Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Kellie Mathis, M.D.

Abierto para la inscripción

Contact information:

Yulia Potter Nichols

(507) 422-9029

PotterNichols.Yulia@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20532500

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