Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cryoprobe Versus Forceps for Transbronchial Biopsy

NCT05751278

Lung Diseases

ACTIVE_NOT_RECRUITING NA

Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules

NCT05230992

Nodule

COMPLETED NA

Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

NCT02983903

Solitary Pulmonary Nodule Multiple Pulmonary Nodules

TERMINATED NA

Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.

NCT05948904

Lung Diseases

RECRUITING NA

Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules

NCT06056882

Pulmonary Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchi--Diseases Lung Diseases, Obstructive Lesions Mass

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard forceps biopsy then research cryoprobe biopsy

Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using forceps first followed by cryoprobe.

Group Type EXPERIMENTAL

Cryoprobe biopsy

Intervention Type DEVICE

A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue

Forceps biopsy

Intervention Type PROCEDURE

Biopsy forceps used to collect tissue

Research cryoprobe biopsy then standard forceps biopsy

Subjects scheduled for a biopsy of lung lesions using robotic bronchoscopy as part of their standard of care will have the lung lesion biopsied using the cryoprobe first followed by forceps.

Group Type EXPERIMENTAL

Cryoprobe biopsy

Intervention Type DEVICE

A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue

Forceps biopsy

Intervention Type PROCEDURE

Biopsy forceps used to collect tissue

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cryoprobe biopsy

A 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue

Intervention Type DEVICE

Forceps biopsy

Biopsy forceps used to collect tissue

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

\- Pulmonary nodules of 8-50mm in largest dimension.

Exclusion Criteria

* Patients with known bleeding diathesis; Platelet count \< 50,000.
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
* Inability or unwillingness to give informed consent.
* Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
* Pulmonary hypertension, defined as a right ventricular systolic pressure \> 50 mmHg.
* Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
* International Normalized Ratio (INR) \< 1.5.
* Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No