Ex vivo cryo-ablation / Lung Cancer · Interventional Study

Establishing Feasibility of Transbronchial Cryoablation With an In-Development Cryoprobe: An Ex-Vivo Human Lung Model

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a planned ex vivo feasibility study of a novel cryoprobe device for lung ablation. The study aims to characterise thermal penetration at defined distances from the probe tip over a 48-month observation window using human cadaveric lung tissue. No results are posted; the record documents study design and planned primary outcome measures only.

What was studied

Interventional, Single Group, Open label, Device Feasibility purpose. Lung Cancer; age from 18 Years. Intervention: Ex Vivo Cryo. n = 10. Not stated in registry record..

Key findings

Safety

Ex vivo model does not directly predict clinical efficacy, safety, or tolerability in patients.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an ex vivo feasibility study of an in-development device with no reported results; it represents early-stage work to establish technical proof of concept before clinical use.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Tissue temperature at 5 mm from the probe over intervention time (assessed at 48 months); Tissue temperature at 10 mm from the probe over intervention time (assessed at 48 months); Tissue temperature at 15 mm from the probe over intervention time (assessed at 48 Months)

DesignInterventional, Single Group, Open label, Device Feasibility purpose

PopulationLung Cancer; age from 18 Years

Sample size10

InterventionEx Vivo Cryo

SettingNot stated in registry record.

Reported figures

Quoted from the source exactly as published.

Planned enrollment10

Primary outcome measure 1Tissue temperature at 5 mm from probe over intervention time, 48 months

Primary outcome measure 2Tissue temperature at 10 mm from probe over intervention time, 48 months

Primary outcome measure 3Tissue temperature at 15 mm from probe over intervention time, 48 months

Caveats

No results reported; this is a study registration only.
Ex vivo model does not directly predict clinical efficacy, safety, or tolerability in patients.
Study has not yet begun recruitment (NOT_YET_RECRUITING status).
No published peer-reviewed data; feasibility alone does not establish clinical utility.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Ex vivo model; not a clinical trial or in vivo validation.

Directness

limited

Bench model; does not measure clinical efficacy or safety in patients.

Consistency

insufficient

Single study; no comparative data or replications reported.

Risk of bias

insufficient

Feasibility/technical study; standard bias assessment tools do not apply.

Sample adequacy

limited

Ten ex vivo lung tissue samples; not applicable to human efficacy or safety.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07104253). This is a study registration, not published results. Lead sponsor: Endocision Technologies Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 10 participants (ESTIMATED). Conditions: Lung Cancer. Interventions: DEVICE: Ex vivo cryo-ablation. Primary outcome measures: Tissue temperature at 5 mm from the probe over intervention time , 48 months; Tissue temperature at 10 mm from the probe over intervention time , 48 months; Tissue temperature at 15 mm from the probe over intervention time , 48 Months. Brief summary: Demonstrate the application of in-development cryogenic catheters for the ablation of pulmonary lesions.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Ex vivo cryo-ablationEndocision TechnologiesNCT07104253Lung Cancer