Optical Breath-hold Control System for Image-guided Procedures

Withdrawn before enrolling · Early Phase 1

Conditions studied: Respiration

In brief

The objective or our study is to test the feasibility of a new optical-based breath-hold control (OBC) system for monitoring breath-hold levels and providing patient feedback during CT-guided biopsies of the lung and upper abdomen where respiratory motion is a problem.

Key facts

Study ID: NCT01062789
Run by: Mayo Clinic
People needed: 0
Starts: 2010-02-01
Expected to finish: 2011-05-01
Last updated by the study team: 2011-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients scheduled for a CT-guided lung or upper abdomen biopsy (including lesions in the liver, pancreas, stomach, kidneys, adrenals, spleen, or in the peritoneum at or above the level of the kidneys) on the SMH-CT-3M scanner when either Dr. Carlson or Dr. Bender are scheduled.
Lesions will need to measure 3 cm or less in maximum dimension and cannot be affixed to the chest or abdominal wall.

You may not qualify if…

Inability to cooperate with breath-holding (including cognitive impairment, poor pulmonary function that inhibits patients from being able to hold their breath for at least 10 seconds)
Patients with bleeding diatheses (platelets < 50,000, International Normalized Ratio > 1.5, or activated partial thromboplastin time > twice normal)
Lesions that abut the pleura or abdominal wall for a distance greater than 3 cm (these lesions were assumed to be fixed in position and less likely to be affected by respiratory motion).
Patients with implanted medical devices (pacemakers) (this exclusion is based on the Division of Engineering Safety Review-enclosed in application)

Where it is running

Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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