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NCT07761351From ClinicalTrials.govRecruiting

A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy

A Randomized Controlled Trial Evaluating Lung Nodules - COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)

  • Lung Cancer (Diagnosis)
  • Lung Nodule

At a glance

Phase
Phase 4
Study type
Interventional
Sponsor
Intuitive Surgical
Enrolment target
550
Started
28 August 2026
Main results due
30 April 2028
Study sites
3
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT).

Study sites(3)

  • 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

Showing 3 of 3 sites. 3 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07761351. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronc | Trialion