CT Guided BiopsyNCT03226535
Ultrasound-CT Fusion System for Interventional Radiology Procedures
A study testing Ultrasound-CT Fusion in people with CT Guided Biopsy and CT Guided Drain Placement Within the Abdomen or Pelvis, run by Clear Guide Medical at 1 site in United States.
Trial summary
The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the patient. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- CT Guided Biopsy, CT Guided Drain Placement Within the Abdomen or Pelvis, CT Guided Injection of Muscle or Nerve Within the Pelvis
- What is being tested?
- Ultrasound-CT Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to 22 Jun 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis)
- Able to give written informed consent
Who cannot join
- Unable to give informed consent
- Patients undergoing CT guided needle-based interventions other than the procedures mentioned in the inclusion criteria
- Prisoners, pregnant women, and children
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Brian Holly, MD, 410-614-1622, bholly3@jhmi.edu
Taylor Dunklin, DA, 410-502-5118, tdunkli1@jhmi.edu
About this study
The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the patient. This fusion system will be used to perform ultrasound guided needle placements for patients undergoing percutaneous CT guided needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is to prove that the new imaging fusion system is comparable to using either CT or US guidance alone to guide needle placement.
Read the detailed description
A simple 20 patient study will be performed using the CG SCENERGY system. This fusion system will be used to perform image guided needle placements for patients undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis). Only patients who are already scheduled for a CT guided procedure will be screened. The study design is as follows:
- 10 patients will have their procedure performed using the CGM SCENERGY US-CT fusion system and 10 patients will have their procedure performed using CT guidance only.
- Proper informed consent will be obtained
- Perform a CT scan with the optical adhesive skin markers in place. Markers are placed around the expected site of needle skin entry.
- The first 10 patients Group#1 (1-10) will be assigned to using the SCENERGY fusion system to complete the needle placement, and the next 10 patients Group #2 (11-20) will be assigned of continuing with CT guidance only to complete the needle placement.
- If in Group #1, the procedure will proceed as usual using the SCENERGY system to guide the needle to target. If in the Group #2, CT guidance will be used to place the needle to target.
- Once the needle is at the target, a confirmatory CT will be performed.
- If the target is reached (i.e., the software directed the interventional radiologist to the right place, e.g. for correctly biopsying a lesion), the trial is considered a "success" and the procedure continues as normal.
- If the needle is not in the right place, the trial is considered a "failure", and the procedure continues as normal without using the CGM software any further.
- Conditions
- CT Guided Biopsy, CT Guided Drain Placement Within the Abdomen or Pelvis, CT Guided Injection of Muscle or Nerve Within the Pelvis
- Being tested
- Ultrasound-CT Fusion
- Keywords
- Computer Assisted Instrument Guidance (CAIG), Ultrasound-CT Fusion, Image Fusion, Clear Guide SCENERGY, Needle path, Needle Guidance, CT, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-CT FusionDevice
Also called Clear Guide SCENERGY
The Clear Guide SCENERGY is an Ultrasound-CT fusion device which supplements existing ultrasound and CT capabilities. The participants randomly selected (out of 20 patients) for use of the Clear Guide SCENERGY (test group) will receive ultrasound-CT fusion guidance from the MDs performing the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-CT Fusion Guidance | Experimental | The participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement. Receives: Device: Ultrasound-CT Fusion |
| CT Guidance | No intervention | The participants in this group (control group) will receive the procedure with traditional CT methods and equipment, for guiding needle placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CT scans or CT fluoroscopic images
Measured: Immediately following intervention (within 2 hours)
Secondary outcomes (3)
Total procedure time
Time from the first CT scan until the needle is at the target
Measured: Immediately following intervention (within 2 hours)
Time to target
Time from needle entering the skin until the needle is at the target
Measured: Immediately following intervention (within 2 hours)
Success of needle placement
A confirmatory CT will be performed to check if the needle reached the target
Measured: Immediately following intervention (within 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start22 Jun 2017
- Primary completion22 Jun 2018 (estimated)
- Study completion22 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT Guided 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Brian Holly, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226535
- Sponsor's protocol ID
- CGM 17-001
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-CT Fusion System for Interventional Radiology Procedures
- ClinicalTrials.gov ID
- NCT03226535
- Acronym / sponsor ID
- CGM 17-001
- Conditions
- CT Guided Biopsy, CT Guided Drain Placement Within the Abdomen or Pelvis, CT Guided Injection of Muscle or Nerve Within the Pelvis
- Keywords
- Computer Assisted Instrument Guidance (CAIG), Ultrasound-CT Fusion, Image Fusion, Clear Guide SCENERGY, Needle path, Needle Guidance, CT, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 22 Jun 2018 (estimated)
- Study completion
- 22 Jun 2018 (estimated)
- First posted
- 21 Jul 2017 (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.
The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the patient. This fusion system will be used to perform ultrasound guided needle placements for patients undergoing percutaneous CT guided needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is to prove that the new imaging fusion system is comparable to using either CT or US guidance alone to guide needle placement.
Detailed description
A simple 20 patient study will be performed using the CG SCENERGY system. This fusion system will be used to perform image guided needle placements for patients undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis). Only patients who are already scheduled for a CT guided procedure will be screened. The study design is as follows:
- 10 patients will have their procedure performed using the CGM SCENERGY US-CT fusion system and 10 patients will have their procedure performed using CT guidance only.
- Proper informed consent will be obtained
- Perform a CT scan with the optical adhesive skin markers in place. Markers are placed around the expected site of needle skin entry.
- The first 10 patients Group#1 (1-10) will be assigned to using the SCENERGY fusion system to complete the needle placement, and the next 10 patients Group #2 (11-20) will be assigned of continuing with CT guidance only to complete the needle placement.
- If in Group #1, the procedure will proceed as usual using the SCENERGY system to guide the needle to target. If in the Group #2, CT guidance will be used to place the needle to target.
- Once the needle is at the target, a confirmatory CT will be performed.
- If the target is reached (i.e., the software directed the interventional radiologist to the right place, e.g. for correctly biopsying a lesion), the trial is considered a "success" and the procedure continues as normal.
- If the needle is not in the right place, the trial is considered a "failure", and the procedure continues as normal without using the CGM software any further.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-CT Fusion Guidance | Experimental | Device: Ultrasound-CT FusionThe participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement. |
| CT Guidance | No intervention | –The participants in this group (control group) will receive the procedure with traditional CT methods and equipment, for guiding needle placement. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis)
- Able to give written informed consent
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Patients undergoing CT guided needle-based interventions other than the procedures mentioned in the inclusion criteria
- Prisoners, pregnant women, and children
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 |
|---|---|---|
| Ultrasound-CT FusionAlso: Clear Guide SCENERGYThe Clear Guide SCENERGY is an Ultrasound-CT fusion device which supplements existing ultrasound and CT capabilities. The participants randomly selected (out of 20 patients) for use of the Clear Guide SCENERGY (test group) will receive ultrasound-CT fusion guidance from the MDs performing the procedure. | Device | Ultrasound-CT Fusion Guidance |
Primary outcome
Number of CT scans or CT fluoroscopic images
Time frame: Immediately following intervention (within 2 hours)
3 secondary outcomes
Total procedure time
Time frame: Immediately following intervention (within 2 hours)
Time to target
Time frame: Immediately following intervention (within 2 hours)
Success of needle placement
Time frame: Immediately following intervention (within 2 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
Brian Holly, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-CT Fusion in people with CT Guided Biopsy and CT Guided Drain Placement Within the Abdomen or Pelvis, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Holly, MD (410-614-1622, bholly3@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CT scans or CT fluoroscopic images (time frame: Immediately following intervention (within 2 hours)). 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 21 Jul 2017.