Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07735611
Status
Not Yet Recruiting

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Conditions

  • Lung; Node

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RAB via the Monarch platform — PROCEDURE
    The 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
    The 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.

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
398 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Monarch Platform
    This study is being conducted at a hospital that has two bronchoscopy procedure rooms (BPRs). The unit of the randomization is the BPR day. Each day, one BPR will be randomized to the Monarch platform and the other to the ION platform. Participants in this arm will have undergone their RAB via the Monarch platform.
  • Other: ION Platform
    This study is being conducted at a hospital that has two bronchoscopy procedure rooms (BPRs). The unit of the randomization is the BPR day. Each day, one BPR will be randomized to the Monarch platform and the other to the ION platform. Participants in this arm will have undergone their RAB via the ION platform.

Primary Outcome Measure

Diagnostic yield defined as the proportion of procedures that result in the acquisition of lesional tissue [ Time Frame: Up to Day 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106
Sameer K Avasarala, MD
[email protected]
Sameer K Avasarala, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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