NCT07761351 A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
| NCT ID | NCT07761351 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Intuitive Surgical |
| Condition | Lung Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2026-08-28 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 550 participants in total. It began in 2026-08-28 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Ricky Thakrar, MD
PRINCIPAL INVESTIGATOR
University College London Hospitals
Frequently Asked Questions
Who can join the NCT07761351 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07761351 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07761351 currently recruiting?
Yes, NCT07761351 is actively recruiting participants. Contact the research team at Encompass@intusurg.com for enrollment information.
Where is the NCT07761351 trial being conducted?
This trial is being conducted at Basel, Switzerland, London, United Kingdom.
Who is sponsoring the NCT07761351 clinical trial?
NCT07761351 is sponsored by Intuitive Surgical. The principal investigator is Ricky Thakrar, MD at University College London Hospitals. The trial plans to enroll 550 participants.
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