At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ion endoluminal system (device)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Ion endoluminal system — device: Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care
- Patient visit burden
- Not specified by the sponsor
In plain English
This European registry study records information from people having a lung biopsy (where a small sample of tissue is taken) and/or a procedure to help doctors find a lesion in the lung, using a device called the Ion endoluminal system. It includes people with a pulmonary nodule (a small lump or spot in the lung) or lung cancer. The study is run by Intuitive Surgical.
Who can take part
- You are aged 18 or older when you agree to take part.
- You are due to have a lung biopsy and/or a procedure to help doctors find a lung lesion, using the Ion endoluminal system.
- You are willing and able to give written informed permission (consent) to take part.
Who may not be able to
- You are taking part in another research study, or one using treatments whose safety is not yet known, if this would affect your taking part or the study results.
- You are pregnant or breastfeeding (checked in the usual way at your hospital or clinic).
- You are not able to give consent yourself, you are in a legal or court-ordered institution, or you are part of a group seen as vulnerable, such as being dependent on the sponsor, the hospital or the study doctor.
- You are not willing to follow the study requirements after your procedure.
- The study doctor believes it is in your best interest not to take part.
What taking part involves
- • Your planned lung biopsy and/or procedure to find or mark the lung lesion, carried out using the Ion endoluminal system.
- • Any other tests, treatments or follow-up procedures: not stated — ask the trial team.
Time commitment: How many visits there are, how long the study lasts, and what the follow-up involves are not stated — ask the trial team; taking part means your planned lung procedure with the Ion system, plus some study requirements after it.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,200
- Started
- 2025-09-09
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary nodule
- • Clinical study - 1,200 participants
- • The objective of this study is to collect collect real-world data for the Ion endoluminal system
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pulmonary nodule
Where?
- • London - University College London Hospitals NHS Foundation Trust
- • Manchester - Wythenshawe Hospital, Manchester University NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
More detail
This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patient is aged 18 years or older at time of consent.
- ✓Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal...
- ✓Patient is willing and able to give written agreement to take part for clinical study participation.
Who cannot take part
- ✗Female patient that is pregnant or breast feeding as determined by standard site practices.
- ✗Patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable...
- ✗Patient is not willing to comply with post-procedure study participation requirements.
- ✗Investigator, in their professional opinion, has decided that it is in the patient's best interest to not...
See the full criteria
Where Is This Study? (2 UK sites)
University College London Hospitals NHS Foundation Trust
London NW1 2BU, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester M23 9LT, United Kingdom
How to Get in Touch
Jana Meschede
Sponsor contactCONTACT
Martha Bean
Sponsor contactCONTACT