Liver BiopsyNCT04039529
Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy
A study testing SCENERGY-guided Biopsy in people with Liver Biopsy and Lung Biopsy, run by Clear Guide Medical at 1 site in United States.
Trial summary
This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Biopsy, Lung Biopsy, Kidney Biopsy
- What is being tested?
- SCENERGY-guided Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy.
Who cannot join
- any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.
Read the detailed description
This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.
- Conditions
- Liver Biopsy, Lung Biopsy, Kidney Biopsy
- Being tested
- SCENERGY-guided Biopsy
- Keywords
- lung biopsy, kidney biopsy, liver biopsy, image fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCENERGY-guided BiopsyDevice
Use of SCENERGY during a lung, liver or kidney biopsy
| Study group | Role | What they receive |
|---|---|---|
| CT-only guided biopsy | No intervention | The current standard of care for biopsy at Temple University Hospital. |
| SCENERGY-guided Biopsy | Experimental | The use of the SCENERGY to fuse CT and Ultrasound for biopsy Receives: Device: SCENERGY-guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dose during Procedure
The number of CTs or Fluoroscopy shots during the biopsy
Measured: 1 hour
Secondary outcomes (2)
Time to Reach Target of Biopsy
The amount of time in seconds that the physician takes to reach the target of biopsy
Measured: 1 hour
Experience Level
Number of years physician has practiced in Interventional Radiology
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start31 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- testing whether biopsies and ablations performed with the SCENERGY result in less patient radiation dose or reduced procedure time compared to biopsies performed under CT-guidance only.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Temple University, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039529
- Sponsor's protocol ID
- TUH SCENERGY
- Status last verified
- Feb 2023
- First submitted
- 29 Jul 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy
- ClinicalTrials.gov ID
- NCT04039529
- Acronym / sponsor ID
- TUH SCENERGY
- Conditions
- Liver Biopsy, Lung Biopsy, Kidney Biopsy
- Keywords
- lung biopsy, kidney biopsy, liver biopsy, image fusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: covid pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Temple University, National Institutes of Health (NIH)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.
Detailed description
This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- testing whether biopsies and ablations performed with the SCENERGY result in less patient radiation dose or reduced procedure time compared to biopsies performed under CT-guidance only.
| Arm | Type | Receives |
|---|---|---|
| CT-only guided biopsy | No intervention | –The current standard of care for biopsy at Temple University Hospital. |
| SCENERGY-guided Biopsy | Experimental | Device: SCENERGY-guided BiopsyThe use of the SCENERGY to fuse CT and Ultrasound for biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy.
Key exclusion criteria (1 listed)
- any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCENERGY-guided BiopsyUse of SCENERGY during a lung, liver or kidney biopsy | Device | SCENERGY-guided Biopsy |
Primary outcome
Radiation Dose during Procedure
Time frame: 1 hour
The number of CTs or Fluoroscopy shots during the biopsy
2 secondary outcomes
Time to Reach Target of Biopsy
Time frame: 1 hour
Experience Level
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCENERGY-guided Biopsy in people with Liver Biopsy and Lung Biopsy, run by Clear Guide Medical at 1 site in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dose during Procedure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.