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Lung Cancer (Diagnosis)Phase 4ENCOMPASSNCT07761351

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

A Phase 4 study testing Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT) and CT-guided percutaneous lung nodule biopsy in people with Lung Cancer (Diagnosis) and Lung Nodule, run by Intuitive Surgical at 3 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer (Diagnosis), Lung Nodule
What is being tested?
Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT) and CT-guided percutaneous lung nodule biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
3 sitesin 3 countries
Study dates
28 Aug 2026to 30 Apr 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Carine Van den Abeele contact

+41 21 821 2000

Encompass@intusurg.com

Martha Bean contact

+41 21 821 2000

Encompass@intusurg.com

3 sites in 3 countries

Germany1 site, 1 recruiting

  • Thoraxklinik Heidelberg

    Heidelberg, 69126

    Felix Herth, MD

    Recruiting

Other trials in Germany

Switzerland1 site, 1 recruiting

  • Basel University Hospital

    Basel, Canton of Basel-City, 4031

    Juegen Hetzel, MD

    Recruiting

Other trials in Switzerland

United Kingdom1 site, 1 recruiting

  • University College London Hospitals NHS Foundation

    London, NW1 2PG

    Ricky Thakrar, MD

    Recruiting

Other trials in United Kingdom

About this study

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

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).

Read the detailed description

CT-guided percutaneous biopsy and ssRAB with CBCT are two types of lung nodule biopsy procedures routinely used in clinical practice. The study is designed to evaluate the diagnostic efficacy and safety of ssRAB with CBCT compared with CT-guided percutaneous lung nodule biopsy in adults requiring diagnostic evaluation of a pulmonary nodule. The co-primary objectives are to assess non-inferiority of diagnostic efficacy and superiority of safety.

The primary endpoints are diagnostic efficacy and the rate of peri-procedural pneumothorax (with or without intervention) associated with the assigned biopsy approach.

Eligible participants will be randomized 1:1 to either ssRAB with CBCT or CT-guided percutaneous lung nodule biopsy. If the clinical team determines that the assigned procedure is not suitable, the participant will receive the most appropriate standard of care instead. Both biopsy procedures will be performed according to routine clinical practice, and no experimental devices or procedures will be used.

Participants will be followed for up to 12 months through medical record review and routine clinical follow-up. Patient-reported quality of life and, optionally, work status will be assessed using questionnaires at multiple time points. No research-specific assessments, burdensome tests, or advanced imaging outside of standard care will be performed. A chest X-ray will be required following the biopsy procedure, consistent with routine clinical practice.

Being tested
Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT), CT-guided percutaneous lung nodule biopsy
Keywords
Lung Biopsy, CT-Guided Percutaneous Biopsy, Robotic-Assisted Bronchoscopy, Shape-Sensing Robotic-Assisted Bronchoscopy (ssRAB), Transthoracic Needle Aspiration (TTNA), Bronchoscopy, Pulmonary Nodules
Medical subject headings
Lung Neoplasms, Disease, Multiple Pulmonary Nodules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)Procedure or surgery

    Also called ssRAB, Ion endoluminal system

    A bronchoscopic lung nodule biopsy procedure performed using shape-sensing robotic-assisted bronchoscopy with cone-beam CT guidance as clinically indicated and according to standard clinical practice.

  • CT-guided percutaneous lung nodule biopsyProcedure or surgery

    Also called Transthoracic Needle Aspiration (TTNA), Transthoracic Needle Biopsy (TTNB)

    A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.

Study groups in NCT07761351
Study groupRoleWhat they receive
Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)Active comparatorParticipants randomized to pulmonary nodule biopsy using shape-sensing robotic-assisted bronchoscopy with cone-beam CT.
Receives: Procedure: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
CT-Guided Percutaneous Lung Nodule BiopsyActive comparatorParticipants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
Receives: Procedure: CT-guided percutaneous lung nodule biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Efficacy of the Assigned Biopsy Procedure

    Diagnostic efficacy will be calculated as the proportion of patients who receive their assigned treatment multiplied by diagnostic yield of their assigned treatment.

    Measured: At the index procedure

  2. Peri-Procedural Pneumothorax Rate

    Rate of peri-procedural pneumothorax related to the assigned index biopsy procedure, including pneumothorax identified on routine post-procedure imaging and clinically relevant pneumothorax requiring intervention or escalation of care.

    Measured: From procedure to 7 days (or until subsequent intervention, whichever occurs first).

Secondary outcomes (9)

  1. Diagnostic Yield

    Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance

    Measured: At the index procedure

  2. Sensitivity for Malignancy

    Sensitivity of the index biopsy procedure for the diagnosis of malignancy, based on final diagnosis established through 1-year follow-up

    Measured: Through 1 year post-procedure

  3. Negative Predictive Value

    Negative predictive value of the index biopsy procedure based on final diagnosis established through 1-year follow-up

    Measured: Through 1 year post-procedure

  4. Diagnostic accuracy

    Diagnostic accuracy of the index biopsy procedure based on final diagnosis established through 1-year follow-up.

    Measured: Through 1 year post-procedure

  5. Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing

    Proportion of biopsy specimens considered adequate for molecular profiling and/or immunohistochemistry (IHC) testing.

    Measured: At the index procedure

  6. Procedure-Related Adverse Events

    Incidence of procedure-related adverse events.

    Measured: Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first

  7. Procedure-related serious adverse events.

    Incidence of procedure-related serious adverse events.

    Measured: Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first

  8. All-Cause Mortality

    Incidence of all-cause mortality among study participants.

    Measured: Through study exit

  9. Length of Stay for Procedure-Related Adverse Events

    Duration of hospitalization attributable to procedure-related adverse events

    Measured: From the date of hospitalization for a procedure-related adverse event until hospital discharge, for events occurring up to 30 days following the index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start28 Aug 2026
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07761351
Sponsor's protocol ID
ISI-RCT-EU4-2025
Acronym
ENCOMPASS
Status last verified
Aug 2026
First submitted
30 Jul 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT) and CT-guided percutaneous lung nodule biopsy in people with Lung Cancer (Diagnosis) and Lung Nodule, run by Intuitive Surgical at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carine Van den Abeele (+41 21 821 2000, Encompass@intusurg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Efficacy of the Assigned Biopsy Procedure (time frame: At the index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07761351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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