Optical Breath-hold Control System for Image-guided Procedures

NCT01062789 | Withdrawn Early Phase 1

• 1 other identifier: 09-004069
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiration

Keywords

lung biopsy; computed tomograph; respiratory motion; Controlling respiratory motion in CT guided lung biopsies; biopsy

Outcome Measures

Primary Outcomes (1)

• Ability to monitor patient respiration (return of target to same anatomical position)

  Measured daily for each individual procedure

Secondary Outcomes (1)

• Needle Placement Time

  Measured daily for each individual procedure

Study Arms (1)

Use of an optical breath-hold control device

OTHER

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)

Interventions

Optical breath-hold control system (OBC) DEVICE

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).

Use of an optical breath-hold control device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie K Carlson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 4, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

US (1)