Recruiting

LUMENA Guidance System

Sponsor:

Mayo Clinic

Code:

NCT07822425

Conditions

Biopsy

Ablation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LUMENA Guidance System

Study Details

Brief summary:

The purpose of this study is to evaluate the feasibility and safety of using the LUMENA guidance system during clinical procedures in patients undergoing CT-guided needle Placement for kidney, liver, lymph node, abdominal mass and lung ablation/biopsy.

Conditions

Biopsy

Ablation

Study ID

NCT07822425

Start date

Sep 17, 2026

Status verified date

Sep, 2026

Completion date

Sep 16, 2028

Anticipated

Primary completion date

Sep 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

INCLUSION CRITERIA

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, ages 18-90 years
  • Patient referred to Interventional Radiology for CT-guided needle placement for ablation/biopsy.

EXCLUSION CRITERIA

  • Patients who are unable to give informed consent themselves or through their parents.
  • Patients that do not fit into the gantry of the CT scanner.
  • Patients who are sensitive to radiation exposure such as pregnant women.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: LUMENA Augmented Reality Guidance

Participants will undergo clinically indicated CT-guided needle placement for ablation or biopsy with use of the LUMENA augmented reality guidance system.

Interventions

LUMENA Guidance System

LUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.

Primary outcome measure

  • Feasibility of completing the CT-guided needle placement procedure using the LUMENA guidance system [ Time Frame: 2 years ]
  • Safety of CT-guided needle placement using the LUMENA guidance system as assessed by adverse events [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Nic Dybel

904-953-4324dybel.nicolas@mayo.edu

Julia Santos

904-953-3280santos.julia@mayo.edu

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Riley Nichols

904-953-7783

Principal Investigator:

David Sella, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-16.