Optical Breath-hold Control System for Image-guided Procedures (OBC)

This study has been withdrawn prior to enrollment.
(Closed due to funding and never enrolled a subject)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01062789
First received: January 28, 2010
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Respiration
Device: Optical breath-hold control system (OBC)
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of an Optical Breath-hold Control (OBC) System for Image-guided Interventional Radiology Procedures: A Feasibility Study

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Ability to monitor patient respiration (return of target to same anatomical position) [ Time Frame: Measured daily for each individual procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Needle Placement Time [ Time Frame: Measured daily for each individual procedure ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Use of an optical breath-hold control device
This is a feasibility study that will use this new device in place of a different bellows-based breath-hold control device for a series patients undergoing CT-guided lung biopsy. The new belt will be used in all patients in our study.
Device: Optical breath-hold control system (OBC)
The OBC system was designed to replace the IBC rubber bellows respiration sensor system that we are currently using for CT-guided lung biopsies. Unlike the IBC, the OBC is 1) unaffected by temperature changes, 2) has a linear sensitivity (for easier use and better accuracy), 3) has no pneumatic purge time when setting reference breath-hold level (reducing the chance of an inappropriate reference), 4) has no pneumatic cable that can occasionally interfere and get pinched during procedures, 5) is ambulatory (so patients can more easily familiarize themselves with the device before the procedure), 6) is capable of indicating proper fitting tension, 7) allows for easier binding (wireless pairing with other system components), and 8) is significantly less expensive (and possibly disposable).

Detailed Description:
  1. Specific Aim #1: To further test the feasibility of the new OBC system for guiding accurate and reproducible breath-hold levels that correlate with internal target position in human volunteers. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to accuracy and reproducibility of a reference breath-hold level.
  2. Specific Aim #2: To compare the use of 2 optical-based belts (wrapped around the chest and abdomen) versus 1 optical-based belt (wrapped around the chest or abdomen, depending on which region expands the most during respiration) with regard to accuracy and reproducibility of a pre-determined reference breath-hold level in a subset of patients (prone and/or obese). Hypothesis: The use of 2 optical-based belts allows increased accuracy and reproducibility of a pre-determined reference breath-hold level compared with the use of only one belt in this subset of patients.
  3. Specific Aim #3: To test the clinical feasibility of the new OBC system in patients undergoing CT-guided biopsy of the lung or upper abdomen where respiratory motion is a problem. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to the accuracy and reproducibility of the reference breath-hold and ease of use.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062789

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Stephanie K Carlson, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Stephanie K. Carlson, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01062789     History of Changes
Other Study ID Numbers: 09-004069
Study First Received: January 28, 2010
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
lung biopsy
computed tomograph
respiratory motion
Controlling respiratory motion in CT guided lung biopsies
biopsy

ClinicalTrials.gov processed this record on April 20, 2014