A Study of Spiration Valves Against Standard Therapy

Overview

About this study

The purpose of this study is to evaluate treatment of persistent air leaks with the Spiration Valve System as compared to standard chest tube drainage management and other standard-of-care interventions.

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

Has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
Has air leak present on at least the 5th day following origination

Exclusion Criteria

Has air leak only on forced exhalation or cough
Has sepsis
Has pneumonia
Has Acute Respiratory Distress Syndrome (ARDS)
Is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
Has undergone a bone marrow transplant
Has a primary pneumothorax
Has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement

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
Rochester, Minn. Mayo Clinic principal investigator K Robert Shen, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

K Robert Shen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials