Comparing CT-guided Lung Biopsy vs Shape-Sensing Robotic Bronchoscopy for Small Nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ENCOMPASS trial is a multicenter, randomized study of adults with diagnostic nodules 2 cm or smaller to compare two biopsy approaches. Participants are randomly assigned to shape-sensing robotic-assisted bronchoscopy with cone-beam CT or to CT-guided percutaneous biopsy. The study aims to show non-inferior diagnostic efficacy and superior safety for the robotic approach, with peri-procedural pneumothorax as a key safety endpoint. Procedures follow standard clinical practice, and patients are followed up to 12 months with health status and quality-of-life assessments. If a patient’s assigned procedure is deemed unsuitable by the clinical team, they receive the best available standard care instead.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is aged 18 years or older at time of consent.
2. Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent).
3. Target pulmonary nodule ≤2 cm in largest diameter.
4. Patient is willing and able to give written informed consent for clinical study participation.

Exclusion Criteria:

1. Patient has previously undergone a biopsy procedure of the target nodule by any approach.
2. Patient was previously randomized in this study but did not undergo biopsy.
3. Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
4. Patient is pregnant or breastfeeding as determined by standard site practices.
5. Patient lacks the capacity to provide informed consent for themselves, or is a vulnerable patient whose ability to protect their own interests or to consent freely may be diminished, including but not limited to, patients who may be unduly influenced through dependency on the sponsor, the hospital, or the study doctor.
6. Patient is not willing to comply with study participation requirements.

Where it's running

• Thoraxklinik Heidelberg
  Heidelberg, Germany Recruiting
• Basel University Hospital
  Basel, Canton of Basel-City, Switzerland Recruiting
• University College London Hospitals NHS Foundation
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Ricky Thakrar, MD — University College London Hospitals
• Study coordinator: Carine Van den Abeele
• Email: Encompass@intusurg.com
• Phone: +41 21 821 2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.