Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing.

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07685977
Status
Not Yet Recruiting

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Conditions

  • Peripheral Pulmonary Lesions (PPLs)

Eligibility Criteria

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

Interventions

  • Rapid onsite evaluation — OTHER
    ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy

Study Details

ARTEMIS is a multicenter randomized controlled trial. The goal is to understand whether rapid onsite evaluation during robotic assisted bronchoscopy improves the diagnostic performance of the procedure or not.

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2029

Study Design

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

Arms

  • Active Comparator: Robotic assisted bronchoscopy with ROSE
    Participants allocated to the robotic assisted bronchoscopy arm with rapid onsite evaluation will have ROSE available during the procedure
  • Active Comparator: Robotic assisted bronchoscopy without ROSE
    Participants allocated to the robotic assisted bronchoscopy arm without rapid onsite evaluation will not have ROSE available during the procedure

Primary Outcome Measure

Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue. [ Time Frame: 7 days post procedure ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Mary Carns Research coordinator
(312) 503-1137
Christopher Kapp, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Kimberly Saulsberry Research coordinator
773-251-8260
James Katsis, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Jenna Loss Research coordinator
410-955-5000
Jeffrey Thiboutot, MD (PRINCIPAL_INVESTIGATOR)
Lahey Hospital and Medical CenterBurlingtonMassachusetts01805
Alyssa Marie B Loessi Research coordinator
781-744-1192
Carla Lamb, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Shanti Persuad Research coordinator
332-699-7260
Lonny Yarmus, DO (PRINCIPAL_INVESTIGATOR)
University of North Carolina Medical CenterChapel HillNorth Carolina27154
Kelsey Haywood Research coordinator
984-974-1000
Jason Akulian, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Michael Balassone Research coordinator
843-792-2300
Christopher Gilbert, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Sanja Antic Research coordinator
(615) 322-5000
Rafael Paez, MD (PRINCIPAL_INVESTIGATOR)

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