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

RecruitingPhase 4Ages 18 Years - anyAllIntuitive Surgical
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In plain words

What the trial is, and whether it could suit you

The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (โ‰ค2 cm): CT-guided percutaneous lung nodule biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค2 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.
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What it tests

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

3 sites
Thoraxklinik Heidelberg
Heidelberg, Germany
Basel University Hospital
Basel, Switzerland
University College London Hospitals NHS Foundation
London, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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