Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: (the RELIANT Trial) (RELIANT)

September 28, 2023 updated by: Fabien Maldonado, Vanderbilt University Medical Center
This is an investigator-initiated, cluster randomized controlled trial. The primary objective is to compare the diagnostic yield of the Ion™ Endoluminal System (SSCB) to the ILLUMISITE™ Platform (EMN bronchoscopy) in patients undergoing bronchoscopy for peripheral pulmonary lesion (PPL) evaluation.

Study Overview

Detailed Description

Peripheral pulmonary lesions (PPLs) are often biopsied to assess for the presence of infection, inflammation, or malignancy. Tissue can be acquired in a variety of ways: surgical resection, percutaneous transthoracic needle biopsy, or bronchoscopic biopsy. Bronchoscopy is commonly pursued to determine PPL etiology, with over 500,000 performed annually in the US alone. Advanced imaging and navigational guidance systems are required to accurately approach small peripheral lesions bronchoscopically. A variety of navigational technologies are currently available, including electromagnetic navigational bronchoscopy (EMN), virtual bronchoscopy, thin and ultrathin bronchoscopes, and endobronchial ultrasound. No comparative data exist regarding the relative performance of these competing technologies, which are all considered standard of care and currently used interchangeably based on personal preferences and availability.

EMN platforms dominate the current navigational bronchoscopy market. The largest prospective multicenter study assessing EMN performance showed a diagnostic yield of 73%. The more recent addition of intraprocedural digital tomosynthesis has been reported to increase EMN diagnostic yield to 75-83%; this feature is included in the ILLUMISITE™ electromagnetic navigational bronchoscopy platform (Medtronic, Minneapolis, MN, U.S.) and is labeled "fluoroscopic navigation".

Recently, the FDA cleared a novel navigational technology: shape-sensing catheter bronchoscopy (SSCB), via the 510(k) pathway. This pathway requires a technical demonstration of safety and efficacy similar to that of an existing predicate device but does not usually require clinical data. Since market release in 2019, single-center prospective cohort data have emerged suggesting SSCB diagnostic yield is comparable to EMN, but no high-quality comparative data exist regarding the relative performance of these two technologies. Despite this important knowledge/data gap, SSCB has become a popular platform in the advanced bronchoscopist community. High-quality comparative data are required to inform optimal patient care. Additionally, EMN and SSCB platforms are considered capital purchases, each costing hundreds of thousands of dollars. Hence, it is also important for health care systems to have high quality data as they consider device purchases. VUMC currently utilizes both SSCB and EMN and they are used interchangeably in our two operating rooms. Patients are typically assigned arbitrarily to procedures using either platform based on operating room availability.

Thus, the investigator proposes a randomized controlled study to test the hypothesis that the diagnostic yield of SSCB is not inferior to EMN in patients undergoing bronchoscopy to biopsy a PPL.

Study Type

Interventional

Enrollment (Estimated)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

18 years of age or older at time of bronchoscopy.

Scheduled for navigational bronchoscopy for the evaluation of a peripheral pulmonary lesion.

Exclusion Criteria:

Enrolled in a different study requiring use of one of these specific platforms (i.e., ILLUMISITE™ Platform (EMN) or Ion™ Endoluminal System (SSCB)).

Subject declines to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ILLUMISITE™ Platform (EMN bronchoscopy)
Participants in the ILLUMISITE™ Platform arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.
Active Comparator: Ion™ Endoluminal System (SSCB bronchoscopy)
Participants in the Ion™ Endoluminal System arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.
Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield, defined as the proportion of procedures that results in acquisition of lesional tissue. Lesional tissue is defined by the presence of histopathological findings that readily explain the presence of a pulmonary lesion.
Time Frame: 7 days post-enrollment

The following common histopathological findings are pre-specified as lesional:

Lesional

i. Malignant

ii. "Specific benign" findings accounting for the presence of a PPL

  1. organizing pneumonia, or
  2. frank purulence/robust neutrophilic inflammation, or
  3. granulomatous inflammation, or
  4. other specific benign finding findings such as hamartoma, amyloidoma or other uncommon causes of PPLs with distinctive pathological patterns.
7 days post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of procedure
Time Frame: Duration of procedure, approximately 60 minutes
Defined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures
Duration of procedure, approximately 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fabien Maldonado, MD, MSc, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.

IPD Sharing Time Frame

The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.

IPD Sharing Access Criteria

Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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