A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
Recruiting · NCT07761351 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
CT-guided percutaneous lung nodule biopsyShape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patient is aged 18 years or older at time of consent.
- Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent).
- Target pulmonary nodule ≤2 cm in largest diameter.
- Patient is willing and able to give written informed consent for clinical study participation.
Exclusion criteria
- Patient has previously undergone a biopsy procedure of the target nodule by any approach.
- Patient was previously randomized in this study but did not undergo biopsy.
- 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.
- Patient is pregnant or breastfeeding as determined by standard site practices.
- 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.
- Patient is not willing to comply with study participation requirements.
Where it is running
2 locations listed.
- University College London Hospitals NHS Foundation - London, United Kingdom
- Basel University Hospital - Basel, Canton of Basel-City, Switzerland