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NCT07761351Recruiting

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

Summary

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).

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 4
Study type
Interventional
Countries
Switzerland, Germany, United Kingdom
Sponsor
Intuitive Surgical(Industry)
Protocol no.
ISI-RCT-EU4-2025
Conditions
Lung Cancer (Diagnosis), Lung Nodule
Interventions
Procedure

Treatments studied

  • Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
  • CT-guided percutaneous lung nodule biopsy

Locations · 3

  • Basel, SwitzerlandBasel University HospitalRecruiting at this site
  • Heidelberg, GermanyThoraxklinik HeidelbergRecruiting at this site
  • London, United KingdomUniversity College London Hospitals NHS FoundationRecruiting at this site

In total, worldwide, all 3 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 25, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.