NCT07530744

Brief Summary

In order to secure the diagnosis of lung cancer, the investigator will perform a bronchoscopy in order to take tissue samples. These samples will be analyzed in the pathology. This is the routine standard. The aim of the study is to treat the lesion with a device that works both with cold and radiofrequency. The device is already in use for the treatment of lesions. The device allows direct treatment of the lesion during the routine bronchoscopy. As planned, the lesion will then be surgically removed. After the surgery the lesion will be analyzed in the pathology to show the effect of the use of the device. This additional treatment is safe and will support the treatment of the lesion. There are no additional steps or assessments for the participants to undergo.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress5%
May 2026Oct 2028

First Submitted

Initial submission to the registry

March 26, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

March 26, 2026

Last Update Submit

April 7, 2026

Conditions

NSCLCCryotherapyRFA

Keywords

Tumor Staging and Resection

Outcome Measures

Primary Outcomes (1)

  • Successful device use, defined as the completion of ablation with the HybridTherm® system with investigator confirmation that the ablation zone achieved sufficient coverage based on intra-procedural imaging.

    during procedure

Secondary Outcomes (6)

  • Safety outcomes, with a specific focus on bleeding events, graded according to the Nashville Bleeding Scale, and the occurrence of other adverse events as documented in the medical record.

    up to 6 - 7 weeks post procedure

  • Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (H&E staining).

    within 24 hours after procedure

  • Visual estimation of histopathologic ablation completeness, defined as the estimated percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting.

    within 24 hours after procedure

  • Evaluation of macroscopic and microscopic necrosis within the ablation zone (histopathologic complete response hpCR), defined as the absence of viable tumor cells within the ablated area, if reported as part of routine histological assessment.

    within24 hours after procedure

  • Descriptive intra-procedural metrics, recorded during the bronchoscopy procedure: Total ablation time; Number of cryoRFA activations; Electrical parameters of energy delivered during the procedure; Number of probe repositioning within the lesion

    day 0

  • +1 more secondary outcomes

Study Arms (1)

Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection

EXPERIMENTAL
Device: Cryotherapy

Interventions

CryotherapyDEVICE

Transbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection

Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility Detailspregnant or breastfeeding women are to be excluded
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Solitary nodule ≤ 2.5 cm
  • Candidate for diagnostic bronchoscopy \& LN staging
  • Eligible for surgical resection
  • Histologically proven lung cancer
  • ≥20 mm margin to pleura/vessels/bronchi
  • Signed informed consent, age ≥18 y.

You may not qualify if:

  • Pregnancy/nursing
  • central tumours abutting vital structures
  • thoracic electronic implants
  • uncorrectable coagulopathy or platelets ≤50 × 10⁹/L
  • severe uncontrolled comorbidities or infection; prior SBRT to zone
  • recent investigational therapy (\<30 d)
  • atelectasis/obstructive pneumonitis/effusion/fibrosis
  • investigator-determined risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordensklinikum Linz Elisabethinen

Linz, Austria

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Christopher Lambers

    Elisabethinen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienne Seil

CONTACT

0043 732 7676 4492adrienne.seil@ordensklinikum.at

Julia Dort

CONTACT

0043 732 7676 4648juliabianca.dort@ordensklinikum.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.Doz.Dr

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 15, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

AU(1)