NCT05399082

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

May 20, 2022

Results QC Date

July 8, 2024

Last Update Submit

October 15, 2024

Conditions

Bronchi--DiseasesLung Diseases, ObstructiveLesions Mass

Outcome Measures

Primary Outcomes (1)

  • Ability to Successfully Obtain Sample

    Number of tissue samples that are considered by the bronchoscopist as adequate for further pathological analysis

    Baseline

Secondary Outcomes (9)

  • Duration of Biopsy Procedure

    Biopsy procedure, approximately 3 hours

  • Freezing Time for Cryoprobe Biopsies

    Biopsy procedure, approximately 60 seconds

  • Number of Successful Biopsy Attempts

    Biopsy procedure, approximately 3 hours

  • Histological Accessibility Grade

    Pathology review, approximately 1 day

  • Histological Diagnostic Yield

    Pathology review, approximately 1 day

  • +4 more secondary outcomes

Study Arms (2)

Standard forceps biopsy then research cryoprobe biopsy

EXPERIMENTAL

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.

Device: Cryoprobe biopsyProcedure: Forceps biopsy

Research cryoprobe biopsy then standard forceps biopsy

EXPERIMENTAL

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.

Device: Cryoprobe biopsyProcedure: Forceps biopsy

Interventions

Cryoprobe biopsyDEVICE

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

Research cryoprobe biopsy then standard forceps biopsyStandard forceps biopsy then research cryoprobe biopsy
Forceps biopsyPROCEDURE

Biopsy forceps used to collect tissue

Research cryoprobe biopsy then standard forceps biopsyStandard forceps biopsy then research cryoprobe biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Bronchial DiseasesLung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases

Results Point of Contact

Title
Ryan M. Kern, M.D.
Organization
Mayo Clinic
Kern.Ryan@mayo.edu
507-266-3958

Study Officials

  • Ryan Kern, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 1, 2022

Study Start

August 15, 2022

Primary Completion

July 11, 2023

Study Completion

July 11, 2023

Last Updated

October 17, 2024

Results First Posted

October 17, 2024

Record last verified: 2024-10

Locations

US(1)