Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
ConditionLung; Node
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
This is an investigator-initiated cluster randomized control trial. The primary objective is to compare the diagnostic yield of two Food and Drug Administration (FDA) cleared national robotic assisted bronchoscopy platforms - the Monarch™ Platform and the ION™ Endoluminal System - in participants undergoing bronchoscopy to evaluate peripheral pulmonary lesions (PPLs). Participants will undergo their scheduled robotic assisted bronchoscopy (RAB) using one of these platforms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at the time of bronchoscopy.
Scheduled to undergo navigational bronchoscopy (either ION™ or Monarch™) for the evaluation of a pulmonary lesion at University Hospitals Cleveland Medical Center (UHCMC).
Able and willing to provide written informed consent.
Disqualifiers
Enrolled in another clinical trial that requires the use of a specific navigational/robotic bronchoscopy platform.
Enrolled in another bronchoscopy-related clinical trial.
Participant or legally authorized representative declines participation.
Trial design
Design model
Parallel
Treatments tested in this trial
RAB via the Monarch platform
Procedure/SurgeryThe Monarch™ (Monarch) platform is one of two FDA-cleared robotic platforms currently in clinical use for robotic-assisted bronchoscopy (RAB). It uses a hybrid approach combining electromagnetic tracking and robotic catheter control with a continuously visualizing bronchoscope (4-way articulation). A key feature of the Monarch platform is direct bronchoscopic vision throughout navigation, enabling real-time assessment of the airways and the target lesion.
RAB via the ION platform
Procedure/SurgeryThe ION™ Endoluminal System (ION) platform is one of two FDA-cleared robotic platforms currently in clinical use for robotic-assisted bronchoscopy (RAB). It uses shape-sensing fiber-optic technology to track catheter position with high precision throughout the bronchial tree.
Treatment groups
398 Participants
are divided into 2 treatment groupsGroup A: Monarch PlatformOther 1 intervention
Group B: ION PlatformOther 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic yield defined as the proportion of procedures that result in the acquisition of lesional tissue
Diagnostic yield is defined as the proportion of procedures that result in the acquisition of lesional tissue. This will be measured for both procedures conducted via the Monarch platform and the ION platform.
Time frame
Up to Day 14Secondary outcomes
1
Duration of the robotic bronchoscopy procedures
The duration of the robotic bronchoscopy procedure will be measured in minutes for both the Monarch platform and the ION platform.
Time frame
Day 02
Safety, measured by the number of complications
Safety will be measured by the number of complications that occur within 7 days of the procedure for both the Monarch platform group and the ION platform group.
Time frame
Up to Day 73
Radiation exposure
Radiation exposure is defined as the radiation dose delivered to the participant during the study bronchoscopy and is recorded as a dose area product in milligray per centimeters squared (mGy/cm2). Radiation exposure is measured for both the Monarch platform group and the ION platform group.
Time frame
Day 04
Rate of additional diagnostic procedures required within 12 months
The rate of additional diagnostic procedures required within 12 months of the study bronchoscopy will be assess for both the Monarch platform group and the ION group.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: