Robot-Assisted heat treatment for lung tumors tested – but study stopped early

NCT ID NCT05299606

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to treat lung tumors that have spread from other cancers. Doctors used a robotic bronchoscope to guide a microwave probe directly into the tumor and heat it to destroy the cancer cells. The study planned to enroll more people but was stopped early after only 12 participants. The main goal was to see if the ablation completely covered the tumor, checked by CT scan 30 days later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
microwave ablation device (NEUWAVE FLEX) guided by robotic bronchoscopy (Auris MONARCH Platform)
What this could lead to
If successful, this approach could offer a less invasive way to destroy lung tumors that have spread from other cancers, potentially reducing the need for surgery or radiation.
What could go wrong
The study was terminated early with only 12 participants, so results are very limited. It is unclear if the technique is safe or effective in the long term, and it may not work for all tumor types or locations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Oct 2022

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: * Signed informed consent. * Subjects greater or equal to 22 years old. * Performance status 0-2 (Eastern Cooperative Oncology Group classification (ECOG). * Willing to fulfill all follow-up visit requirements. * Subjects with at least one oligometastatic lung tumor where the primary tumor is controlled (in the opinion of the investigator or treating oncologist). * Oligometastatic lung tumor(s) planned to be ablated in the outer two-thirds of the lung and not closer than 1cm to the pleura. EXCLUSION CRITERIA: * Pregnant or breastfeeding. * Subjects with thoracic implantable devices, including pacemakers or other electronic implants. * Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions. (However, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted). * Prior pneumonectomy. * Severe bronchiectasis (with FEV1 \<30%) or disease deemed to be too severe in the opinion of the investigator. * Platelet count ≤ 50,000/mm3. * Subjects with uncorrectable coagulopathy at time of screening. * Subjects medically unable to stop anti-platelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days prior to the procedure through 48-72 hours after the procedure. * Subjects medically unable to stop warfarin at least 3-5 days prior to the ablation procedure, or until INR \< 1.5, through 48-72 hours after the procedure. On the day of the procedure, subjects with an INR \> 1.5 cannot have the procedure completed that day but may be rescheduled or postponed. * Subjects medically unable to stop anticoagulants (e.g., rivaroxaban, apixaban, dabigatran, endoxaban) at least 3 days prior to the ablation procedure through 48-72 hours after the procedure. * Expected survival less than 6 months in the opinion of the investigator and/or treating oncologist. * Subjects with known or suspected brain metastases. * Subject has had any radiation (i.e., SBRT or EBRT) to the intended ablation zone. * Endobronchial tumors proximal to and including the segmental airways. * Lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned study ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation). * Systemic therapy (e.g., chemotherapy, targeted drug therapy, or immunotherapy) within 14 days prior to the planned study ablation procedure or those who plan to receive systemic therapy before completing the primary endpoint assessment (30 days post-ablation).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, Canada

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407, United States

  • Prince of Wales Hospital

    Shatin, Hong Kong

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • UCONN Health

    Farmington, Connecticut, 06030, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Toronto

    Toronto, Ontario, Canada

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