Recruiting

Monarch™ vs. ION™

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07735611

Conditions

Lung; Node

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RAB via the Monarch platform

RAB via the ION platform

Study Details

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

Study ID

NCT07735611

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

398 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

RAB via the Monarch platform

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

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.

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 and Locations

Central contacts

Sameer K Avasarala, MD

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

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Sameer K Avasarala, MD

Sameer.Avasarala@uhhospitals.org

Principal Investigator:

Sameer K Avasarala, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.