Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)

NCT07735611 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CASE3526
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung; Node

Keywords

Bronchoscopy; Robotic assisted bronchoscopy; Monarch™; ION™ Endoluminal System

Outcome Measures

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.

  Up to Day 14

Secondary Outcomes (5)

• Duration of the robotic bronchoscopy procedures

  Day 0

• Safety, measured by the number of complications

  Up to Day 7

• Radiation exposure

  Day 0

• Rate of additional diagnostic procedures required within 12 months

  Up to 12 months

• Diagnostic accuracy at 12 months post-biopsy

  Up to 12 months

Study Arms (2)

Monarch Platform

OTHER

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.

Procedure: RAB via the Monarch platform

ION Platform

OTHER

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.

Procedure: RAB via the ION platform

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.

Also known as: Monarch™

Monarch Platform

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.

Also known as: ION™ Endoluminal System

ION Platform

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Sameer K Avasarala, MD

  Case Comprehensive Cancer Center, University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameer K Avasarala, MD

CONTACT

216-844-3201; Sameer.Avasarala@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is being conducted at University Hospitals, where there are two bronchoscopy procedure rooms (BPR). The unit of randomization is the BPR day. Each BPR day constitutes one cluster. The robotic bronchoscopy platform assigned to each BPR each day is determined by random allocation each morning via sealed, opaque, day-of-week-stratified envelopes prepared by a biostatistician not involved in clinical care or participant scheduling.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by University Hospitals Institutional Review Board and the study executive committee.

Locations

US (1)